This job is in your area. Enjoy a short commute and work close to home.
Job Description
Job Summary
:The Manager, Global CAPA System is responsible for designing, implementing, and sustaining an effective global CAPA system to ensure regulatory compliance, product quality, and continuous improvement across all regions and sites. This role provides strategic leadership, governance, and subject matter expertise for CAPA processes arising from, but not limited to, deviations, nonconformances, audit and inspection findings, product complaints, adverse events, trend analyses, and risk management outputs.
Own and maintain the global CAPA program, including policies, procedures, workflows, and performance metrics.
Ensure alignment of CAPA processes with global regulatory requirements 21 CFR Part 820, 21 CFR Parts 210/211, ISO 13485, the FDA Quality Management System Regulation (QMSR), and the EU Medical Device Regulation (EU MDR).
Establish clear criteria for CAPA initiation, escalation, prioritization, effectiveness checks, and ...