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.

• 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 closure.

• Serve as the global subject matter expert (SME) for CAPA-related regulatory expectations and best practices.

• Lead, develop, and sustain high-performing global and site CAPA teams; set clear expectations, coach performance, and build deep technical expertise across sites in investigations, root cause analysis, CAPA effectiveness, and quality risk management.

• Partner cross‑functionally with Quality, Regulatory Affairs, Manufacturing, R&D, Supply Chain, and Commercial teams to drive effective root cause analysis, ensure timely closure of CAPAs, and prevent recurrence of quality issues.

• Oversee CAPA activities resulting from, but not limited to, deviations, nonconformances, audit and inspection findings, product complaints, adverse events, trend analyses, and risk management outputs.

• Review and approve root cause analyses using structured methodologies (e.g., 5 Whys, Fishbone, Fault Tree, FMEA, etc.).

• Ensure CAPA action plans are scientifically sound, data-driven, risk-based, and sustainable.

• Monitor CAPA effectiveness and ensure verification of lasting corrective/preventive outcomes.

• Develop and maintain global CAPA KPIs, dashboards, and management review inputs.

• Perform trending and statistical analysis to identify systemic issues, recurring failures, or emerging risks.

• Lead continuous improvement initiatives to reduce CAPA cycle time, improve quality maturity, and enhance inspection readiness.

• Act as CAPA lead during regulatory inspections, notified body audits, and internal quality audits, including responses to observations and non-conformances.

• Ensure i