QMS Specialist: CAPA, Audits & Regulatory Compliance

Posted 16 days ago

highridge medicalWestminster (CO)

Quality Control Systems Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

Highridge Medical seeks a Quality Management System Specialist to ensure the organization’s QMS complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP. The role administers eQMS related to CAPAs and NCs, drives CAPA activities including trending, and supports audits and regulatory inspections to maintain patient safety and product quality. The position leads CAPA programs, trains staff on CAPA processes, and coordinates health hazard evaluation and field action programs.

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