Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Headquartered in Silicon Valley, California, Archer is a leader in the next-gen aerospace sector building an end-to-end advanced air mobility platform that delivers air taxis, unmanned aircraft systems ("UAS"), aviation-related physical artificial intelligence ("AI") solutions, and other technologies to customers worldwide across the commercial aerospace and defense sectors. Our sights are set high and our problems are hard, and we believe that diversity in the workplace is what makes us smarter, drives better insights, and will ultimately lift us all to success. We are dedicated to cultivating an equitable and inclusive environment that embraces our differences, and supports and celebrates all of our team members. What You'll Do As a Staff DevOps Engineer, you will architect, develop, and scale the core services, real-time data pipelines, and distributed infrastructure that power our cutting-edge AI products. You will bridge the gap between complex AI models and production-ready systems, ensuring that our high-throughput, real-time data streaming environment is reliable, secure, and infinitely scalable. Architect and maintain highly available backend systems, distributed data pipelines, and scalable cloud infrastructure to support real-time AI applications. Leverage infrastructure-as-code (IaC) and cloud-native tooling to build, manage, and optimize our production, staging, and development environments. Build and manage stream-processing jobs capable of handling global, high-frequency data streams with ultra-low latency. Work cross-functionally with AI Research, Engineering, and Data Science teams to containerize, deploy, orchestrate, and monitor scalable ML models and infrastructure. Own the full development lifecycle-from system design and infrastructure provisioning to deployment, proactive monitoring, and capacity planning. Maximize system performance, observability, and reliability; respond to high-priority production issues with advanced debugging, root cause analysis, and blameless post-mortems. Mentor and guide team members, fostering an engineering culture centered around DevOps practices, automation, and distributed systems best practices. What You Need BS/MS/PhD degree in Computer Science, Software Engineering, or a related technical field. 5+ years of professional software engineering experience with a heavy focus on backend systems, distributed architectures, and infrastructure management. Strong proficiency in Java, Python and/or Rust, with a solid grasp of writing high-performance, concurrent backend code. Production experience with stream-processing frameworks, specifically Apache Flink. Experience setting up observability stacks (eg Grafana, Prometheus, ELK, etc.) Solid experience with containerization and orchestration (Docker, Kubernetes), including configuring network policies, storage, and auto-scaling. Deep experience with cloud platforms (AWS, GCP, or Azure) and infrastructure-as-code tools such as OpenTofu/Terraform and Ansible. Hands-on experience with modern GitOps practices (e.g., Argo CD) and managing CI/CD automation pipelines. Solid experience with relational databases (e.g., PostgreSQL), in-memory datastores (e.g., Valkey/Redis), and high-throughput data storage strategies. Able to scale yourself with AI coding assistants while still fully understanding and taking absolute ownership of all code and infrastructure configurations you commit. Excellent communication skills, with a proven ability to design resilient architectures and explain complex infrastructure paradigms to the broader team. Bonus Qualifications Deep experience with Apache Pulsar (or Kafka) handling high-throughput, event-driven streaming architectures. Rust experience with async runtimes (Tokio) and message-driven architectures. Experience architecting real-time media pipelines using WebRTC (LiveKit, RealtimeKit) with a focus on server-side jitter buffering and network impairment handling. Deep understanding of audio codecs, specifically optimizing server-side Opus encoding/decoding for CPU efficiency and low-latency distribution. Familiarity with MLOps frameworks, GPU orchestration in Kubernetes, and serving LLMs at scale. Background in high-availability, real-time systems, telecommunications, or safety-critical networks. Prior experience or a deep interest in aerospace, aviation, or autonomous tracking systems. Please note that this job description is intended to provide a general overview of the position and does not include an exhaustive list of responsibilities and qualifications. At Archer we aim to attract, retain, and motivate talent that possess the skills and leadership necessary to grow our business. We drive a pay-for-performance culture and reward performance that supports the Company's business strategy. For this position we are targeting a base pay between $200,000 - $250,000. Actual compensation offered will be determined by factors such as job-related knowledge, skills, and experience. Archer is proud to be an Equal Opportunity employer committed to diversity and inclusivity in the workplace. All aspects of employment are decided on the basis of merit, qualifications, and business needs. We do not discriminate based upon race, color, religion, sex, sexual orientation, age, national origin, disability status, protected veteran status, gender identity or any other characteristic protected by federal, state or local laws. Archer is committed to working with and providing reasonable accommodations to job applicants with physical or mental disabilities, and those with sincerely held religious beliefs. Applicants who may require reasonable accommodation for any part of the application or hiring process should provide their name and contact information to Archer's People Team at . Reasonable accommodations will be determined on a case-by-case basis. Information collected and processed as part of any job applications you choose to submit is subject to Archer's Candidate Privacy Policy. Certain positions may be eligible for visa sponsorship. Archer is proud to be an Equal Opportunity employer committed to diversity and inclusivity in the workplace. All aspects of employment are decided on the basis of merit, qualifications, and business needs. We do not discriminate based upon race, color, religion, sex, sexual orientation, age, national origin, disability status, protected veteran status, gender identity or any other characteristic protected by federal, state or local laws. Archer Aviation does not engage with external recruiting agencies/individual recruiters with whom it does not have a prior written agreement. Archer reserves the right to make use of any unsolicited resumes that it receives and bears no responsibility for payment of any fees asserted from the use of unsolicited resumes. If you are a recruiting agency or individual recruiter wishing to do business with Archer, please reach out to . All employment processes are managed by the Archer People Team.
09/25/2026
Full time
Headquartered in Silicon Valley, California, Archer is a leader in the next-gen aerospace sector building an end-to-end advanced air mobility platform that delivers air taxis, unmanned aircraft systems ("UAS"), aviation-related physical artificial intelligence ("AI") solutions, and other technologies to customers worldwide across the commercial aerospace and defense sectors. Our sights are set high and our problems are hard, and we believe that diversity in the workplace is what makes us smarter, drives better insights, and will ultimately lift us all to success. We are dedicated to cultivating an equitable and inclusive environment that embraces our differences, and supports and celebrates all of our team members. What You'll Do As a Staff DevOps Engineer, you will architect, develop, and scale the core services, real-time data pipelines, and distributed infrastructure that power our cutting-edge AI products. You will bridge the gap between complex AI models and production-ready systems, ensuring that our high-throughput, real-time data streaming environment is reliable, secure, and infinitely scalable. Architect and maintain highly available backend systems, distributed data pipelines, and scalable cloud infrastructure to support real-time AI applications. Leverage infrastructure-as-code (IaC) and cloud-native tooling to build, manage, and optimize our production, staging, and development environments. Build and manage stream-processing jobs capable of handling global, high-frequency data streams with ultra-low latency. Work cross-functionally with AI Research, Engineering, and Data Science teams to containerize, deploy, orchestrate, and monitor scalable ML models and infrastructure. Own the full development lifecycle-from system design and infrastructure provisioning to deployment, proactive monitoring, and capacity planning. Maximize system performance, observability, and reliability; respond to high-priority production issues with advanced debugging, root cause analysis, and blameless post-mortems. Mentor and guide team members, fostering an engineering culture centered around DevOps practices, automation, and distributed systems best practices. What You Need BS/MS/PhD degree in Computer Science, Software Engineering, or a related technical field. 5+ years of professional software engineering experience with a heavy focus on backend systems, distributed architectures, and infrastructure management. Strong proficiency in Java, Python and/or Rust, with a solid grasp of writing high-performance, concurrent backend code. Production experience with stream-processing frameworks, specifically Apache Flink. Experience setting up observability stacks (eg Grafana, Prometheus, ELK, etc.) Solid experience with containerization and orchestration (Docker, Kubernetes), including configuring network policies, storage, and auto-scaling. Deep experience with cloud platforms (AWS, GCP, or Azure) and infrastructure-as-code tools such as OpenTofu/Terraform and Ansible. Hands-on experience with modern GitOps practices (e.g., Argo CD) and managing CI/CD automation pipelines. Solid experience with relational databases (e.g., PostgreSQL), in-memory datastores (e.g., Valkey/Redis), and high-throughput data storage strategies. Able to scale yourself with AI coding assistants while still fully understanding and taking absolute ownership of all code and infrastructure configurations you commit. Excellent communication skills, with a proven ability to design resilient architectures and explain complex infrastructure paradigms to the broader team. Bonus Qualifications Deep experience with Apache Pulsar (or Kafka) handling high-throughput, event-driven streaming architectures. Rust experience with async runtimes (Tokio) and message-driven architectures. Experience architecting real-time media pipelines using WebRTC (LiveKit, RealtimeKit) with a focus on server-side jitter buffering and network impairment handling. Deep understanding of audio codecs, specifically optimizing server-side Opus encoding/decoding for CPU efficiency and low-latency distribution. Familiarity with MLOps frameworks, GPU orchestration in Kubernetes, and serving LLMs at scale. Background in high-availability, real-time systems, telecommunications, or safety-critical networks. Prior experience or a deep interest in aerospace, aviation, or autonomous tracking systems. Please note that this job description is intended to provide a general overview of the position and does not include an exhaustive list of responsibilities and qualifications. At Archer we aim to attract, retain, and motivate talent that possess the skills and leadership necessary to grow our business. We drive a pay-for-performance culture and reward performance that supports the Company's business strategy. For this position we are targeting a base pay between $200,000 - $250,000. Actual compensation offered will be determined by factors such as job-related knowledge, skills, and experience. Archer is proud to be an Equal Opportunity employer committed to diversity and inclusivity in the workplace. All aspects of employment are decided on the basis of merit, qualifications, and business needs. We do not discriminate based upon race, color, religion, sex, sexual orientation, age, national origin, disability status, protected veteran status, gender identity or any other characteristic protected by federal, state or local laws. Archer is committed to working with and providing reasonable accommodations to job applicants with physical or mental disabilities, and those with sincerely held religious beliefs. Applicants who may require reasonable accommodation for any part of the application or hiring process should provide their name and contact information to Archer's People Team at . Reasonable accommodations will be determined on a case-by-case basis. Information collected and processed as part of any job applications you choose to submit is subject to Archer's Candidate Privacy Policy. Certain positions may be eligible for visa sponsorship. Archer is proud to be an Equal Opportunity employer committed to diversity and inclusivity in the workplace. All aspects of employment are decided on the basis of merit, qualifications, and business needs. We do not discriminate based upon race, color, religion, sex, sexual orientation, age, national origin, disability status, protected veteran status, gender identity or any other characteristic protected by federal, state or local laws. Archer Aviation does not engage with external recruiting agencies/individual recruiters with whom it does not have a prior written agreement. Archer reserves the right to make use of any unsolicited resumes that it receives and bears no responsibility for payment of any fees asserted from the use of unsolicited resumes. If you are a recruiting agency or individual recruiter wishing to do business with Archer, please reach out to . All employment processes are managed by the Archer People Team.
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/24/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/24/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
09/24/2026
Full time
Job DescriptionJob Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance people's lives, delivering well-being through pure products, unique experiences, and an unparalleled passion for the plant. For more than a decade, PAX has provided products that are simple, enjoyable, and trusted by millions. PAX has been recognized for its brand, culture and products by The New York Times' Wirecutter, TIME, Fast Company, GQ, Gear Patrol, mg Magazine, High Times, and many more. PAX is committed to making a positive impact through PEACE BY PAX, its purpose-driven platform supporting social reform, safe access and sustainability. We are incredibly excited about the progress of the movement, the tremendous growth of the industry, and inspired every day by our opportunity to help change lives through cannabis. Our culture is focused on putting people at the center of everything we do, making an impact together, and having fun along the way. Our team has an unparalleled passion for the plant and has helped build business at the forefront of consumer experience and well-being, including Apple, Google, Uber, Fitbit, Constellation, Honest Company, Beauty Counter, Eaze, Curaleaf, Wyld and more. PAX has raised over $430MM in capital from leading consumer and technology investors and is available for sale in some capacity in more than 40 countries around the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain PAX's Quality Management System (QMS) while serving as the primary quality authority for our medical device launch in Germany. Balancing fast-paced consumer hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 9001 standards to ensure our physical devices meet the highest quality and safety benchmarks. Reporting to the CEO, you will hold independent go/no-go release authority, oversee design controls and risk management (ISO 14971), and lead cross-functional alignment across Engineering, Operations, and Regulatory Affairs. Your work will directly ensure audit readiness for notified bodies and position our regulated hardware portfolio for successful Germany expansion. ROLE AND RESPONSIBILITIES Quality Management System (QMS) Own, maintain, and continuously improve PAX's QMS, structured around ISO 13485 and ISO 9001 principles and scaled appropriately to each product line's regulatory status. Define the quality policy, quality objectives, and QMS scope, and ensure the system stays current as products, processes, and regulations evolve. Lead management review meetings, reporting quality metrics, risks, and system performance to the CEO and executive team. Determine which QMS elements apply to which product lines (consumer vs. medical-market hardware) and make the call on where to hold the line versus where to right-size process for a growing company. Design & Development Quality (Test Plans, Test Reports, V&V) Review and approve test plans and test reports for new product development and sustaining engineering changes, ensuring test methods, sample sizes, acceptance criteria, and statistical rationale are sound. Own quality's role in design controls: design inputs/outputs, verification and validation planning, design reviews, and design history file (DHF) content and completeness. Partner with Engineering from concept through launch so quality and testability requirements are built in early rather than inspected in at the end. Make independent go/no-go quality calls on design transfer and product release, backed by objective evidence. Risk Management Own the risk management process (aligned to ISO 14971 principles), including hazard identification, risk analysis, risk controls, and residual risk evaluation for hardware and (where applicable) software. Ensure risk files are living documents, updated through the product lifecycle and revisited on complaints, CAPAs, and design changes. Document & Records Control Implement and run a formal document control system: numbering, revision control, approval routing, distribution, and obsolescence for specifications, procedures, work instructions, and forms. Own records retention and traceability - device history records, inspection records, training records, and audit trails - so any product or decision can be reconstructed on demand. Select, implement, and administer the document control / eQMS tooling as the company scales beyond manual processes. Supplier & Manufacturing Quality Establish supplier quality requirements, qualification criteria, and ongoing performance monitoring (incoming inspection, supplier audits, scorecards) for contract manufacturers and component suppliers. Own incoming inspection, in-process, and outgoing quality control specifications and sampling plans in partnership with Operations and contract manufacturers. Drive supplier corrective action for quality escapes and manage first-article and production-readiness reviews for new suppliers or tooling. CAPA, Nonconformance & Complaint Handling Own the CAPA (corrective and preventive action) process end to end: intake, root-cause analysis, effectiveness checks, and closure, across manufacturing, field, and internal findings. Run the nonconformance process for in-process and incoming material issues, including disposition (use-as-is, rework, scrap) decisions. Own product complaint handling and post-market surveillance data, identifying trends that warrant CAPA, design change, or regulatory reporting. Internal Audit & Regulatory Quality Support Plan and execute the internal audit program against QMS procedures and applicable standards; track findings to closure. Serve as the primary quality point of contact for external audits and regulatory inspections (notified bodies, certification bodies, customers). Partner closely with Regulatory Affairs on EU MDR technical documentation and quality-system evidence for medical-market cannabis devices, ensuring quality records and design controls satisfy MDR requirements. Leadership & Cross-Functional Partnership Build the quality function's roadmap, headcount plan, and budget as PAX's regulated product portfolio grows; hire and develop quality engineers and document control staff over time. Act as a direct, independent voice on quality and risk in cross-functional and executive discussions - comfortable saying no to a launch date when the evidence doesn't support it. Train and coach Engineering, Operations, and Sales teams on quality-system expectations and their role in maintaining compliance. QUALIFICATIONS 10+ years of progressive quality engineering / quality systems experience in a regulated hardware environment (medical device, IVD, combination product, or similarly regulated consumer hardware). Direct, hands-on experience with ISO 13485 and/or 21 CFR 820 (or the FDA QMSR) quality management systems, including having built or substantially matured a QMS from the ground up. Demonstrated experience reviewing and approving test plans, test reports, and V&V documentation for physical/electromechanical hardware products. Practical experience running document control, CAPA, nonconformance, supplier quality, and internal audit programs. Working knowledge of risk management per ISO 14971 or equivalent. Proven ability to operate independently and make final quality decisions (including release holds) with minimal oversight, and to communicate those decisions clearly to executive stakeholders. Bachelor's degree in engineering, a physical science, or a related technical field (or equivalent practical experience). PREFERRED QUALIFICATIONS: Direct experience with EU MDR technical documentation and/or notified body audits. ASQ certification (CQE, CQM/OE, CMQ/OE) or ISO 13485 Lead Auditor certification. Experience standing up or administering an eQMS platform (e.g., MasterControl, Greenlight Guru, Qualio, ETQ). Experience in cannabis, vaporization, consumer electronics, or a comparably fast-moving hardware category that had to layer regulatory rigor onto an existing consumer product line. Experience managing or mentoring a small quality team. What Success Looks Like A functioning, audit-ready QMS with document control, CAPA, and risk management processes in active use, not just on paper. Test plans and reports are reviewed with a consistent, defensible standard before design and release decisions are made. PAX's medical-market cannabis devices have the quality-system evidence needed to support EU MDR submissions without last-minute scrambles. Engineering, Operations, and Sales see Quality as an independent, trusted partner - not a rubber stamp or a roadblock. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. PAX LABS PERKS & BENEFITS Competitive compensation, equity & bi-annual performance reviews Fully funded comprehensive medical, dental, and vision coverage 401K plan Generous PTO policy Paid Parental Leave Monthly wellness reimbursement Cell Phone reimbursement Employee Purchase Program for discounted PAX devices . click apply for full job details
Join our dynamic Data Center Engineering Operations Team and become a critical architect of the infrastructure that powers global cloud computing. You'll play a pivotal role in maintaining the heartbeat of Amazon Web Services' physical infrastructure, ensuring seamless operations that support millions of customers worldwide. The Data Center Chief Engineer (CE) is responsible for ensuring that all electrical, mechanical, and fire/life safety equipment within the data center is operating at peak efficiency. This involves planned preventative maintenance of equipment, daily corrective work, and emergency response. The CE serves as an expert technical resource interacting with onsite Engineering Operations Technicians (EOT) and any third-party vendors. They are expected to be a singular focal point for all facility operations within a given data center and to support AWS. AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help. You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion. NOTE: Amazon does not sponsor for immigration, including for H-1B, TN, and other non-immigrant visas, for this role. NOTE: Relocation assistance will be provided to eligible candidates who relocate for this position. This opportunity is located within the greater Lubbock area in Floydada, TX. Key job responsibilities Act as the primary escalation point for all facilities-related issues. Oversee operation and management of routine and emergency services on a variety of critical systems such as switchgear, generators, UPS systems, power distribution equipment, chillers, cooling towers, computer room air handlers, building monitoring systems, etc. Perform root cause analysis of equipment failures and troubleshooting of facility within internal Service Level Agreements (SLA). Provide training and guidance to Engineering Operations Technicians and are responsible for working with Facility Manager (FM) to set team culture. Create and deploy new standard practices for Engineering Operations Technicians, Chief Engineers, and vendor support teams May assist in the building out of new facilities and assist in projects to increase current facility efficiency Working outside of normal business hours for routine maintenance as required, including responding to out-of-hours emergency calls. Communicate complex technical information to a non-technical audience. Work with IT managers and other business leaders to coordinate projects, manage capacity, and optimize plant safety, performance, reliability and efficiency Ensure all safety procedures are adhered to by vendor and Amazon staff Establish building performance benchmarks, conduct analyses, and prepare reports on all aspects of the critical facility of operations and maintenance. Utilize Microsoft Excel, Word, Outlook and other basic administrative tools to perform day-to-day tasks Physical Requirements: Willingness and demonstrated ability to work in the following physical conditions with reasonable accommodation: Regularly lift and/or move up to 39 pounds independently Participate in group lifts for 40+ pounds Maintain balance and perform construction tasks while on a ladder Regularly walk, use hands and fingers, handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb stairs, twist, bend, work above shoulders, grasp, carry, push and pull objects into position Work in an environment requiring provided ear protection Essential Requirements: • Ability to travel to or commute between data center locations as needed • Willingness to temporarily work at alternative sites during training periods or until assigned facility is operational • Travel frequency will vary based on business needs and operational status of assigned facility Candidates must be able to travel (over 50 miles) or commute (less than 50 miles) to active data center sites as required by business needs. BASIC QUALIFICATIONS - 3+ years of electrical and mechanical facilities maintenance, or 3+ years of electrical facilities maintenance and 2+ years of mechanical facilities maintenance experience - Experience reading and writing procedures, technical documents, and engineering drawings - 3+ years of Microsoft Office products and applications experience PREFERRED QUALIFICATIONS - Experience in data center engineering or operations - Experience in construction or project management - Experience leading technical teams through daily operations and maintenance evolutions - Can work in an environment that involves walking, stooping, bending, and climbing to access equipment Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, TX, Lubbock - 96 300.00 USD annually
09/22/2026
Full time
Join our dynamic Data Center Engineering Operations Team and become a critical architect of the infrastructure that powers global cloud computing. You'll play a pivotal role in maintaining the heartbeat of Amazon Web Services' physical infrastructure, ensuring seamless operations that support millions of customers worldwide. The Data Center Chief Engineer (CE) is responsible for ensuring that all electrical, mechanical, and fire/life safety equipment within the data center is operating at peak efficiency. This involves planned preventative maintenance of equipment, daily corrective work, and emergency response. The CE serves as an expert technical resource interacting with onsite Engineering Operations Technicians (EOT) and any third-party vendors. They are expected to be a singular focal point for all facility operations within a given data center and to support AWS. AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help. You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion. NOTE: Amazon does not sponsor for immigration, including for H-1B, TN, and other non-immigrant visas, for this role. NOTE: Relocation assistance will be provided to eligible candidates who relocate for this position. This opportunity is located within the greater Lubbock area in Floydada, TX. Key job responsibilities Act as the primary escalation point for all facilities-related issues. Oversee operation and management of routine and emergency services on a variety of critical systems such as switchgear, generators, UPS systems, power distribution equipment, chillers, cooling towers, computer room air handlers, building monitoring systems, etc. Perform root cause analysis of equipment failures and troubleshooting of facility within internal Service Level Agreements (SLA). Provide training and guidance to Engineering Operations Technicians and are responsible for working with Facility Manager (FM) to set team culture. Create and deploy new standard practices for Engineering Operations Technicians, Chief Engineers, and vendor support teams May assist in the building out of new facilities and assist in projects to increase current facility efficiency Working outside of normal business hours for routine maintenance as required, including responding to out-of-hours emergency calls. Communicate complex technical information to a non-technical audience. Work with IT managers and other business leaders to coordinate projects, manage capacity, and optimize plant safety, performance, reliability and efficiency Ensure all safety procedures are adhered to by vendor and Amazon staff Establish building performance benchmarks, conduct analyses, and prepare reports on all aspects of the critical facility of operations and maintenance. Utilize Microsoft Excel, Word, Outlook and other basic administrative tools to perform day-to-day tasks Physical Requirements: Willingness and demonstrated ability to work in the following physical conditions with reasonable accommodation: Regularly lift and/or move up to 39 pounds independently Participate in group lifts for 40+ pounds Maintain balance and perform construction tasks while on a ladder Regularly walk, use hands and fingers, handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb stairs, twist, bend, work above shoulders, grasp, carry, push and pull objects into position Work in an environment requiring provided ear protection Essential Requirements: • Ability to travel to or commute between data center locations as needed • Willingness to temporarily work at alternative sites during training periods or until assigned facility is operational • Travel frequency will vary based on business needs and operational status of assigned facility Candidates must be able to travel (over 50 miles) or commute (less than 50 miles) to active data center sites as required by business needs. BASIC QUALIFICATIONS - 3+ years of electrical and mechanical facilities maintenance, or 3+ years of electrical facilities maintenance and 2+ years of mechanical facilities maintenance experience - Experience reading and writing procedures, technical documents, and engineering drawings - 3+ years of Microsoft Office products and applications experience PREFERRED QUALIFICATIONS - Experience in data center engineering or operations - Experience in construction or project management - Experience leading technical teams through daily operations and maintenance evolutions - Can work in an environment that involves walking, stooping, bending, and climbing to access equipment Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, TX, Lubbock - 96 300.00 USD annually
Join our dynamic Data Center Engineering Operations Team and become a critical architect of the infrastructure that powers global cloud computing. You'll play a pivotal role in maintaining the heartbeat of Amazon Web Services' physical infrastructure, ensuring seamless operations that support millions of customers worldwide. The Data Center Chief Engineer (CE) is responsible for ensuring that all electrical, mechanical, and fire/life safety equipment within the data center is operating at peak efficiency. This involves planned preventative maintenance of equipment, daily corrective work, and emergency response. The CE serves as an expert technical resource interacting with onsite Engineering Operations Technicians (EOT) and any third-party vendors. They are expected to be a singular focal point for all facility operations within a given data center and to support AWS. AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help. You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion. NOTE: Amazon does not sponsor for immigration, including for H-1B, TN, and other non-immigrant visas, for this role. NOTE: Relocation assistance will be provided to eligible candidates who relocate for this position. Key job responsibilities Act as the primary escalation point for all facilities-related issues. Oversee operation and management of routine and emergency services on a variety of critical systems such as switchgear, generators, UPS systems, power distribution equipment, chillers, cooling towers, computer room air handlers, building monitoring systems, etc. Perform root cause analysis of equipment failures and troubleshooting of facility within internal Service Level Agreements (SLA). Provide training and guidance to Engineering Operations Technicians and are responsible for working with Facility Manager (FM) to set team culture. Create and deploy new standard practices for Engineering Operations Technicians, Chief Engineers, and vendor support teams May assist in the building out of new facilities and assist in projects to increase current facility efficiency Working outside of normal business hours for routine maintenance as required, including responding to out-of-hours emergency calls. Communicate complex technical information to a non-technical audience. Work with IT managers and other business leaders to coordinate projects, manage capacity, and optimize plant safety, performance, reliability and efficiency Ensure all safety procedures are adhered to by vendor and Amazon staff Establish building performance benchmarks, conduct analyses, and prepare reports on all aspects of the critical facility of operations and maintenance. Utilize Microsoft Excel, Word, Outlook and other basic administrative tools to perform day-to-day tasks Physical Requirements: Willingness and demonstrated ability to work in the following physical conditions with reasonable accommodation: Regularly lift and/or move up to 39 pounds independently Participate in group lifts for 40+ pounds Maintain balance and perform construction tasks while on a ladder Regularly walk, use hands and fingers, handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb stairs, twist, bend, work above shoulders, grasp, carry, push and pull objects into position Work in an environment requiring provided ear protection Essential Requirements: • Ability to travel to or commute between data center locations as needed • Willingness to temporarily work at alternative sites during training periods or until assigned facility is operational • Travel frequency will vary based on business needs and operational status of assigned facility Candidates must be able to travel (over 50 miles) or commute (less than 50 miles) to active data center sites as required by business needs. BASIC QUALIFICATIONS - 3+ years of electrical and mechanical facilities maintenance, or 3+ years of electrical facilities maintenance and 2+ years of mechanical facilities maintenance experience - Experience reading and writing procedures, technical documents, and engineering drawings - 3+ years of Microsoft Office products and applications experience PREFERRED QUALIFICATIONS - Experience in data center engineering or operations - Experience in construction or project management - Experience leading technical teams through daily operations and maintenance evolutions - Can work in an environment that involves walking, stooping, bending, and climbing to access equipment Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, NV, SPARKS - 96 300.00 USD annually
09/22/2026
Full time
Join our dynamic Data Center Engineering Operations Team and become a critical architect of the infrastructure that powers global cloud computing. You'll play a pivotal role in maintaining the heartbeat of Amazon Web Services' physical infrastructure, ensuring seamless operations that support millions of customers worldwide. The Data Center Chief Engineer (CE) is responsible for ensuring that all electrical, mechanical, and fire/life safety equipment within the data center is operating at peak efficiency. This involves planned preventative maintenance of equipment, daily corrective work, and emergency response. The CE serves as an expert technical resource interacting with onsite Engineering Operations Technicians (EOT) and any third-party vendors. They are expected to be a singular focal point for all facility operations within a given data center and to support AWS. AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help. You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion. NOTE: Amazon does not sponsor for immigration, including for H-1B, TN, and other non-immigrant visas, for this role. NOTE: Relocation assistance will be provided to eligible candidates who relocate for this position. Key job responsibilities Act as the primary escalation point for all facilities-related issues. Oversee operation and management of routine and emergency services on a variety of critical systems such as switchgear, generators, UPS systems, power distribution equipment, chillers, cooling towers, computer room air handlers, building monitoring systems, etc. Perform root cause analysis of equipment failures and troubleshooting of facility within internal Service Level Agreements (SLA). Provide training and guidance to Engineering Operations Technicians and are responsible for working with Facility Manager (FM) to set team culture. Create and deploy new standard practices for Engineering Operations Technicians, Chief Engineers, and vendor support teams May assist in the building out of new facilities and assist in projects to increase current facility efficiency Working outside of normal business hours for routine maintenance as required, including responding to out-of-hours emergency calls. Communicate complex technical information to a non-technical audience. Work with IT managers and other business leaders to coordinate projects, manage capacity, and optimize plant safety, performance, reliability and efficiency Ensure all safety procedures are adhered to by vendor and Amazon staff Establish building performance benchmarks, conduct analyses, and prepare reports on all aspects of the critical facility of operations and maintenance. Utilize Microsoft Excel, Word, Outlook and other basic administrative tools to perform day-to-day tasks Physical Requirements: Willingness and demonstrated ability to work in the following physical conditions with reasonable accommodation: Regularly lift and/or move up to 39 pounds independently Participate in group lifts for 40+ pounds Maintain balance and perform construction tasks while on a ladder Regularly walk, use hands and fingers, handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb stairs, twist, bend, work above shoulders, grasp, carry, push and pull objects into position Work in an environment requiring provided ear protection Essential Requirements: • Ability to travel to or commute between data center locations as needed • Willingness to temporarily work at alternative sites during training periods or until assigned facility is operational • Travel frequency will vary based on business needs and operational status of assigned facility Candidates must be able to travel (over 50 miles) or commute (less than 50 miles) to active data center sites as required by business needs. BASIC QUALIFICATIONS - 3+ years of electrical and mechanical facilities maintenance, or 3+ years of electrical facilities maintenance and 2+ years of mechanical facilities maintenance experience - Experience reading and writing procedures, technical documents, and engineering drawings - 3+ years of Microsoft Office products and applications experience PREFERRED QUALIFICATIONS - Experience in data center engineering or operations - Experience in construction or project management - Experience leading technical teams through daily operations and maintenance evolutions - Can work in an environment that involves walking, stooping, bending, and climbing to access equipment Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, NV, SPARKS - 96 300.00 USD annually
Join our dynamic Data Center Engineering Operations Team and become a critical architect of the infrastructure that powers global cloud computing. You'll play a pivotal role in maintaining the heartbeat of Amazon Web Services' physical infrastructure, ensuring seamless operations that support millions of customers worldwide. The Data Center Chief Engineer (CE) is responsible for ensuring that all electrical, mechanical, and fire/life safety equipment within the data center is operating at peak efficiency. This involves planned preventative maintenance of equipment, daily corrective work, and emergency response. The CE serves as an expert technical resource interacting with onsite Engineering Operations Technicians (EOT) and any third-party vendors. They are expected to be a singular focal point for all facility operations within a given data center and to support AWS. AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help. You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion. NOTE: Amazon does not sponsor for immigration, including for H-1B, TN, and other non-immigrant visas, for this role. NOTE: Relocation assistance will be provided to eligible candidates who relocate for this position. Key job responsibilities Act as the primary escalation point for all facilities-related issues. Oversee operation and management of routine and emergency services on a variety of critical systems such as switchgear, generators, UPS systems, power distribution equipment, chillers, cooling towers, computer room air handlers, building monitoring systems, etc. Perform root cause analysis of equipment failures and troubleshooting of facility within internal Service Level Agreements (SLA). Provide training and guidance to Engineering Operations Technicians and are responsible for working with Facility Manager (FM) to set team culture. Create and deploy new standard practices for Engineering Operations Technicians, Chief Engineers, and vendor support teams May assist in the building out of new facilities and assist in projects to increase current facility efficiency Working outside of normal business hours for routine maintenance as required, including responding to out-of-hours emergency calls. Communicate complex technical information to a non-technical audience. Work with IT managers and other business leaders to coordinate projects, manage capacity, and optimize plant safety, performance, reliability and efficiency Ensure all safety procedures are adhered to by vendor and Amazon staff Establish building performance benchmarks, conduct analyses, and prepare reports on all aspects of the critical facility of operations and maintenance. Utilize Microsoft Excel, Word, Outlook and other basic administrative tools to perform day-to-day tasks Physical Requirements: Willingness and demonstrated ability to work in the following physical conditions with reasonable accommodation: Regularly lift and/or move up to 39 pounds independently Participate in group lifts for 40+ pounds Maintain balance and perform construction tasks while on a ladder Regularly walk, use hands and fingers, handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb stairs, twist, bend, work above shoulders, grasp, carry, push and pull objects into position Work in an environment requiring provided ear protection Essential Requirements: • Ability to travel to or commute between data center locations as needed • Willingness to temporarily work at alternative sites during training periods or until assigned facility is operational • Travel frequency will vary based on business needs and operational status of assigned facility Candidates must be able to travel (over 50 miles) or commute (less than 50 miles) to active data center sites as required by business needs. BASIC QUALIFICATIONS- 3+ years of electrical and mechanical facilities maintenance, or 3+ years of electrical facilities maintenance and 2+ years of mechanical facilities maintenance experience - Experience reading and writing procedures, technical documents, and engineering drawings - 3+ years of Microsoft Office products and applications experience PREFERRED QUALIFICATIONS- Experience in data center engineering or operations - Experience in construction or project management - Experience leading technical teams through daily operations and maintenance evolutions - Can work in an environment that involves walking, stooping, bending, and climbing to access equipment Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, NV, SPARKS - 96 300.00 USD annually
09/17/2026
Full time
Join our dynamic Data Center Engineering Operations Team and become a critical architect of the infrastructure that powers global cloud computing. You'll play a pivotal role in maintaining the heartbeat of Amazon Web Services' physical infrastructure, ensuring seamless operations that support millions of customers worldwide. The Data Center Chief Engineer (CE) is responsible for ensuring that all electrical, mechanical, and fire/life safety equipment within the data center is operating at peak efficiency. This involves planned preventative maintenance of equipment, daily corrective work, and emergency response. The CE serves as an expert technical resource interacting with onsite Engineering Operations Technicians (EOT) and any third-party vendors. They are expected to be a singular focal point for all facility operations within a given data center and to support AWS. AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help. You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion. NOTE: Amazon does not sponsor for immigration, including for H-1B, TN, and other non-immigrant visas, for this role. NOTE: Relocation assistance will be provided to eligible candidates who relocate for this position. Key job responsibilities Act as the primary escalation point for all facilities-related issues. Oversee operation and management of routine and emergency services on a variety of critical systems such as switchgear, generators, UPS systems, power distribution equipment, chillers, cooling towers, computer room air handlers, building monitoring systems, etc. Perform root cause analysis of equipment failures and troubleshooting of facility within internal Service Level Agreements (SLA). Provide training and guidance to Engineering Operations Technicians and are responsible for working with Facility Manager (FM) to set team culture. Create and deploy new standard practices for Engineering Operations Technicians, Chief Engineers, and vendor support teams May assist in the building out of new facilities and assist in projects to increase current facility efficiency Working outside of normal business hours for routine maintenance as required, including responding to out-of-hours emergency calls. Communicate complex technical information to a non-technical audience. Work with IT managers and other business leaders to coordinate projects, manage capacity, and optimize plant safety, performance, reliability and efficiency Ensure all safety procedures are adhered to by vendor and Amazon staff Establish building performance benchmarks, conduct analyses, and prepare reports on all aspects of the critical facility of operations and maintenance. Utilize Microsoft Excel, Word, Outlook and other basic administrative tools to perform day-to-day tasks Physical Requirements: Willingness and demonstrated ability to work in the following physical conditions with reasonable accommodation: Regularly lift and/or move up to 39 pounds independently Participate in group lifts for 40+ pounds Maintain balance and perform construction tasks while on a ladder Regularly walk, use hands and fingers, handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb stairs, twist, bend, work above shoulders, grasp, carry, push and pull objects into position Work in an environment requiring provided ear protection Essential Requirements: • Ability to travel to or commute between data center locations as needed • Willingness to temporarily work at alternative sites during training periods or until assigned facility is operational • Travel frequency will vary based on business needs and operational status of assigned facility Candidates must be able to travel (over 50 miles) or commute (less than 50 miles) to active data center sites as required by business needs. BASIC QUALIFICATIONS- 3+ years of electrical and mechanical facilities maintenance, or 3+ years of electrical facilities maintenance and 2+ years of mechanical facilities maintenance experience - Experience reading and writing procedures, technical documents, and engineering drawings - 3+ years of Microsoft Office products and applications experience PREFERRED QUALIFICATIONS- Experience in data center engineering or operations - Experience in construction or project management - Experience leading technical teams through daily operations and maintenance evolutions - Can work in an environment that involves walking, stooping, bending, and climbing to access equipment Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, NV, SPARKS - 96 300.00 USD annually
As a member of the Cloud-Scale Machine Learning Acceleration team you'll be responsible for the design and optimization of Hardware in our data centers including technologies such as AWS Inferentia which is a machine learning inference product designed to deliver high performance at low cost. You'll provide leadership in the application of new technologies to large scale deployments in a continuous effort to deliver a world-class customer experience. This is a fast-paced, intellectually challenging position, and you'll work with thought-leaders in multiple technology areas. You'll have relentlessly high standards for yourself and everyone you work with, and you'll be constantly looking for ways to improve our products' performance, quality and cost. We're changing an industry, and we want individuals who are ready for this challenge and want to reach beyond what is possible today. Key job responsibilities - Drive block physical implementation through synthesis, floor planning, bus / pin planning, place and route, power/clock distribution, congestion analysis, timing closure, IR drop analysis, physical verification, ECO and sign-off - Develop cloud infrastructure to support physical design work. - Drive improvement in RTL2GDS flows/methodology for PPA and TAT improvement. - Create Dashboard/central reports for project tracking and visualizing QoR/stats - Interface directly with RTL, Package Design, DFT and other teams to improve methodologies and efficiencies and drive efforts to resolution. - Work with EDA tool vendors to evaluate new tools, solve bugs, improve usability, etc. BASIC QUALIFICATIONS - Bachelor's degree in Electrical Engineering or a related field - Block Design using EDA tools (examples: Cadence, Mentor Graphics, Synopsys, or Others) including synthesis, equivalency verification, floor planning, bus / pin planning, place and route, power/clock distribution, congestion analysis, timing closure, IR drop analysis, physical verification, and ECO - Deep understanding on sign-off activities (timing, ir/em, physical verification) PREFERRED QUALIFICATIONS - Expertise using CAD tools (examples: Cadence, Mentor Graphics, Synopsys, or Others) develop flows for synthesis, formal verification, floor planning, bus / pin planning, place and route, power/clock distribution, congestion analysis, timing closure, IR drop analysis, physical verification, and ECO - 4+ years of integrating IP and ability to specify and drive IP requirements in the physical domain. - Experience in extraction of design parameters, QOR metrics, and analyzing trends - Meets/exceeds Amazon's leadership principles requirements for this role - Meets/exceeds Amazon's functional/technical depth and complexity for this role Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company's reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, CA, Cupertino - 176 300.00 USD annually USA, TX, Austin - 153 000.00 USD annually
09/15/2026
Full time
As a member of the Cloud-Scale Machine Learning Acceleration team you'll be responsible for the design and optimization of Hardware in our data centers including technologies such as AWS Inferentia which is a machine learning inference product designed to deliver high performance at low cost. You'll provide leadership in the application of new technologies to large scale deployments in a continuous effort to deliver a world-class customer experience. This is a fast-paced, intellectually challenging position, and you'll work with thought-leaders in multiple technology areas. You'll have relentlessly high standards for yourself and everyone you work with, and you'll be constantly looking for ways to improve our products' performance, quality and cost. We're changing an industry, and we want individuals who are ready for this challenge and want to reach beyond what is possible today. Key job responsibilities - Drive block physical implementation through synthesis, floor planning, bus / pin planning, place and route, power/clock distribution, congestion analysis, timing closure, IR drop analysis, physical verification, ECO and sign-off - Develop cloud infrastructure to support physical design work. - Drive improvement in RTL2GDS flows/methodology for PPA and TAT improvement. - Create Dashboard/central reports for project tracking and visualizing QoR/stats - Interface directly with RTL, Package Design, DFT and other teams to improve methodologies and efficiencies and drive efforts to resolution. - Work with EDA tool vendors to evaluate new tools, solve bugs, improve usability, etc. BASIC QUALIFICATIONS - Bachelor's degree in Electrical Engineering or a related field - Block Design using EDA tools (examples: Cadence, Mentor Graphics, Synopsys, or Others) including synthesis, equivalency verification, floor planning, bus / pin planning, place and route, power/clock distribution, congestion analysis, timing closure, IR drop analysis, physical verification, and ECO - Deep understanding on sign-off activities (timing, ir/em, physical verification) PREFERRED QUALIFICATIONS - Expertise using CAD tools (examples: Cadence, Mentor Graphics, Synopsys, or Others) develop flows for synthesis, formal verification, floor planning, bus / pin planning, place and route, power/clock distribution, congestion analysis, timing closure, IR drop analysis, physical verification, and ECO - 4+ years of integrating IP and ability to specify and drive IP requirements in the physical domain. - Experience in extraction of design parameters, QOR metrics, and analyzing trends - Meets/exceeds Amazon's leadership principles requirements for this role - Meets/exceeds Amazon's functional/technical depth and complexity for this role Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company's reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at . USA, CA, Cupertino - 176 300.00 USD annually USA, TX, Austin - 153 000.00 USD annually