Engineer Quality
Core
Independently set quality standards, develop testing methods, and manage vendor quality for medical device production processes.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation (DMRs, 510K submissions)
Domain
Medical Devices / Manufacturing Quality
Required skills
Statistical process control (SPC), experimental design, CAPA management, regulatory compliance (21 CFR 820, ISO13485), supplier qualification, risk management
Preferred skills
Medical Devices industry experience
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Manage process control and validation methods; design and perform product testing; lead supplier quality programs; build regulatory documentation; investigate non-conformances and lead CAPA.
Seniority
Mid-level, hands-on IC