Description Position SummaryThe Principal Quality Engineer is a senior technical leader responsible for ensuring compliance and effectiveness of the Quality Management System (QMS), with a strong focus on Design Controls and Class II medical devices.
This role supports the full product lifecycle-from development through commercialization-ensuring compliance with FDA QMSR, ISO 13485, and ISO 14971, while driving design transfer, process validation, and manufacturing quality.
Essential Duties and ResponsibilitiesThe essential functions include, but are not limited to the following:
Key Responsibilities - Lead Design Controls (21 CFR 820.30) including DVT, V&V, design reviews, DHF, and design transfer
- Provide quality oversight for process development and validation (DVT, IQ/OQ/PQ, PCR, TMV)
- Review and support manufacturing documentation (MVRs, Work Instructions, Procedures, DHRs)
- Lead risk management activities (dFMEA, pFMEA) in alignment with ISO 14971
- Support QMS compliance (FDA QMSR, ISO 13485) and Change Control Board (CCB) activities
- Drive improvements through process capability, yield improvements, and Product Health Reviews
- Support Supplier Qualification and Assessments and CSV activities
- Lead investigations (nonconformance, CAPA, complaints) and root cause analysis
- Partner cross-functionally to support development-to-production transition
- Lead projects, delegate work, and mentor team members
Decision-Making Authority - Independently make technical quality decisions impacting development and manufacturing
- Approve/recommend validation, risk, and design transfer deliverables
- Determine disposition of nonconforming product
- Act as key contributor in CCB decisions
- Escalate risks with recommended actions
Position Requirements Minimum Qualifications (Knowledge, Skills, and Abilities) - Bachelor's degree in Engineering and 7+ years of relevant experience, or
- Master's degree in Engineering with 5+ years of relevant experience
- Experience with Class II medical devices
- Strong knowledge of Design Controls, FDA QMSR, ISO 13485, ISO 14971
- Experience with DVT, IQ/OQ/PQ, TMV
- Strong problem-solving, CAPA, and technical writing skills
Preferred Qualifications - Experience with R&D to manufacturing transfer
- Supplier quality and audit experience
- CSV experience
- Six Sigma or Lean certification
Location Regenesis Biomedical Inc
Full-Time/Part-Time Full-Time
Exempt/Non-Exempt Exempt
This position is currently accepting applications. 
