Principal Quality Engineer

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 lifecyclefrom development through commercializationensuring 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

Required Experience:

Staff IC