Job Description
Provide quality support for manufacturing and product development processes and personnel to assure compliance with Department operating procedures (DOPs) and Good manufacturing practices (GMP) requirements. Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions (e.g., product quality, product transfers, complaints, labeling, validation, automation of systems). Execute the role of project leader for quality-related initiatives. Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, subassemblies, and finished products. Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures. Provide coaching and training for junior members of the quality team. Establish and maintain successful cross-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments. Coordinate corrective actions for issuance, review, and closure of action plans. Telecommuting permitted up to 60% within the Andover, MA area. Full time employment, Monday Friday, 40 hours per week, $148,239.12 per year. MINIMUM REQUIREMENTS: Must have a Bachelors degree in Electronic Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, Computer Science or a related field and 5 years of related work experience. Of the required experience, must have 5 years of experience in: Working in the Medical device industry; Applying regulatory standards such as GMPs, ISO 13485, ISO 14971, ISO 62304, MDD and EU MDR to assess changes to medical devices; Design development and changes in medical devices; Drafting design verification and design validation protocols and reports; Creating and updating risk documentation, including design analysis use failure mode and effects analysis (d/u FMEA), Risk Management Plans, reports, files and hazard analysis; and Participating in Corrective/Preventive Action (CAPA) teams. Of the required experience, must have 3 years of experience leading CAPA teams.