Manager- Global CAPA System

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. 

Work location: Trumbull, CT or Livingston, NJ (on-site)

Scope: 

The Manager, Global CAPA System is responsible for the governance and oversight of CooperSurgical’s global Corrective and Preventive Action (CAPA) program. This role ensures that standardized, effective CAPA processes are implemented and maintained across the organization and are fully compliant with applicable global regulatory requirements, including but not limited to 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).

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.