Manager- Global CAPA System

About CooperSurgical

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

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

Scope:

The Manager Global CAPA System is responsible for the governance and oversight of CooperSurgicals 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 requirements21 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 crossfunctionally 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.

Travel: This position may require 5-10% domestic and/or international travel.

Knowledge Skills and Abilities:

• 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 crossfunctional teams.
• Strong written and verbal communication skills with the ability to influence crossfunctional 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:

• Bachelors degree in Engineering Life Sciences Chemistry or a related discipline required. Masters degree preferred.

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Our Benefits:

As an employee of CooperSurgical youll 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 atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between$120000.00 - $170000.00 annually. Theactual base payincludes 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.