Manager- Global CAPA System

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.

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.