Quality Engineer IV
Core
Ensure compliance with quality system requirements and GMP/ISO standards for medical device manufacturing, leading investigations and validation activities.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Commercialized medical devices (Electrophysiology products)
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (FMEA), Statistical data analysis (Minitab), Process validation (IQ/OQ/PQ/PPQ), Root cause analysis, Six Sigma/SPC, FDA/GMP/ISO 13485 regulations, Project management
Preferred skills
Medical device industry experience, ASQ CQE or Six Sigma certification, Supervision experience, Master's degree
Technologies
Minitab, MS Excel, MS Word, MS PowerPoint
Responsibilities
Verify adherence to Quality System and GMP/ISO standards; Lead Major Quality System investigations (CAPAs, HHEs, StopShip); Conduct NCMR, OOT, and Complaint investigations; Execute and author qualification plans (IQ/OQ/PQ/PPQ); Perform advanced statistical data analyses; Support audits as SME backup; Mentor entry-level personnel.
Seniority
Senior, hands-on IC with supervision responsibilities
