Principal Quality Engineer Regenesis Biomedical Inc - 4.0 Scottsdale, AZ Job Details Full-time 3 hours ago Qualifications Managing medical device teams Document review (document control) Engineering development testing Technical documentation Preventive action implementation Statistical Process Control Production deviation management Engineering process optimization Quality control preventive actions Corrective and preventive actions (CAPA) Change management Collaboration with product development teams Vendor compliance management Production validation processes Quality risk management Team management Decision making Design failure mode and effects analysis (DFMEA) Technology transfer (scale-up process) Compliance documentation Mentoring Leading team collaboration initiatives Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Senior level Escalation handling Delegation Production documentation Continuous process improvement (CPI) Full Job Description Position Summary The 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 Responsibilities The 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