Manager- Global CAPA System

About the role

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).

Responsibilities

• 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 inspection-ready documentation and clear traceability from issue identification through CAPA closure.
• Support regulatory commitments and post-approval change management as applicable.
• Develop and deliver CAPA training programs for global stakeholders.
• Mentor site CAPA owners and quality teams to strengthen root cause analysis and problem-solving capabilities.
• Represent the site and CooperSurgical in external forums (as assigned), including industry events, conventions, seminars, and trainings, maintaining professionalism and protecting company and product reputation.
• Perform other duties as assigned.

Qualifications

• Demonstrated expertise in CAPA management, including root cause analysis, effectiveness checks, and lifecycle governance.
• Strong working knowledge of applicable global regulatory and quality standards, including 21 CFR Part 820, 21 CFR Parts 210/211, ISO 13485, FDA QMSR, and EU MDR.
• Experience supporting regulatory inspections, notified body audits, and internal quality audits, including CAPA-related observation remediation.
• Proficiency with electronic Quality Management Systems (eQMS) and CAPA workflows (e.g., TrackWise, Veeva, MasterControl, etc.).
• Proven ability to analyze quality data and trends to identify systemic issues and drive continuous improvement initiatives.
• Proven ability to operate effectively within a matrixed global organization, influencing cross-functional teams.
• Strong written and verbal communication skills, with the ability to influence cross-functional and global stakeholders.
• Fluent English required; Spanish proficiency strongly preferred (or ability and willingness to quickly develop working proficiency).
• Experience: 8+ years of progressive quality experience in a regulated industry, with 3-5 years directly supporting or managing CAPA systems. 5+ years of QA leadership experience with demonstrated ability to build, lead, and develop high-performing teams.
• Education: Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related discipline required. Master’s degree preferred.