Senior Engineer, Product Quality
Core
Lead Product Quality Engineering (PQE) for assembly and test operations, driving complex quality investigations, risk management, and validation to ensure regulatory compliance and manufacturing performance.
Role type
Senior Product Quality Engineer (PQE)
Builds
Medical device products for life sciences, diagnostics, and biotechnology
Domain
Life sciences / Medical devices / Quality Engineering
Required skills
Medical device risk management, Validation (IQ/OQ/PQ), Quality Management System (QMS) compliance, Root cause analysis (5why, 8D, Fishbone), Continuous improvement, Regulatory standards knowledge (ISO 13485, FDA 21 CFR 820, MDSAP), Cross-functional collaboration
Preferred skills
Mechanical/Electrical/Software engineering background, New Product Introduction (NPI) experience
Technologies
None stated
Responsibilities
Lead quality investigations and CAPA execution, Drive continuous improvement of quality processes, Ensure compliance with global medical device regulations, Develop and maintain Risk Management Files and PFMEA, Collaborate cross-functionally to resolve product quality issues
Seniority
Senior, hands-on IC