Avanos Medical seeks a Principal Design Quality Assurance Engineer to lead design transfer of medical devices from development to manufacturing. In this role, you will own design quality plans, risk management, and verification/validation activities, ensuring compliance with FDA, ISO 13485, and ISO 14971. You will partner closely with R&D, operations, and regulatory teams to establish robust technology transfer processes, qualify suppliers, and resolve nonconformances. This position drives continuous improvement in design controls and product reliability to support safe, effective devices that improve patient outcomes worldwide.
Responsibilities
- Lead design quality assurance for new and existing medical devices
- Own and maintain design control and technology transfer plans
- Drive risk management activities per ISO 14971
- Oversee verification and validation strategy and documentation
- Collaborate with R&D, manufacturing, and regulatory on design transfer
- Ensure compliance with FDA QSR, ISO 13485, and other standards
- Support supplier qualification and control for design-related components
- Investigate and resolve design-related nonconformances and CAPAs
- Implement continuous improvement in design quality processes
- Provide technical quality leadership and mentoring to cross-functional teams
Required Skills
- Design controls for medical devices
- Technology transfer to manufacturing
- Risk management (ISO 14971)
- FDA QSR and ISO 13485 compliance
- Verification and validation (V&V)
- Statistical analysis and DOERoot cause analysis and CAPASupplier quality management
- Technical documentation and DHF management
- Cross-functional project leadership