Sr. Quality Engineer
Core
Maintain quality systems and FDA/ISO compliance for medical device manufacturing operations.
Role type
Senior Quality Engineer (Medical Device Manufacturing)
Builds
Quality systems, control plans, PPAP documentation, and validation processes for medical devices.
Domain
Medical device manufacturing / Quality Engineering
Required skills
Six Sigma, 8D problem-solving, FMEA, GD&T, blueprint reading, metrology, statistical analysis, ISO 13485, FDA 820, GMP, GDP, Minitab, Microsoft Office Suite
Preferred skills
ASQ CQE or CMQ/QE certification, ISO 13485, FDA 820, customer interaction experience, forging/machining operations knowledge
Technologies
Excel, Minitab, Microsoft Word, Outlook, PowerPoint
Responsibilities
Maintain quality systems and environmental/FDA requirements; facilitate operator-owned quality program; partner with manufacturing to resolve quality/cost/schedule issues; prepare FMEAs, control plans, and PPAP documentation; coordinate process validations; generate quality metric reports; investigate customer complaints and manage CAPAs; write quality work instructions; participate in audits and inspections.
Seniority
Senior, hands-on IC