Manager- Global CAPA System
Role details
Job location
Tech stack
Job description
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)., 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.
Requirements
- 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.
Work Environment:
- Onsite Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
- Occasionally lift to 35 pounds.
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.
Benefits & conditions
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team., For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $120,000.00 - $170,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.