Regulatory Quality Engineer - Medical Devices (FDA & ISO 13485)
ARCH
ARCH is seeking a Quality System Management Representative for the Elmhurst, IL and Kenosha, WI facilities to promote regulatory and quality system compliance. The role requires training personnel on the Quality System and regulatory standards, and ensuring processes are established, implemented, and maintained. Responsibilities include leading audits, CAPA, ECO, and MRB activities, developing metrics, and coordinating risk assessments and validation programs under FDA QSR 820 and ISO 13485. #J-18808-Ljbffr ARCH
Vacancy posted 2 days ago
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Description Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards Investigate and address customer complaints... ...Profile 5+ years of quality experience in medical device Understanding of ISO13485 and FDA standards Experience...Local area
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