Regulatory Quality Engineer – Medical Devices (FDA & ISO 13485)

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.