Capa System Engineer Jobs (NOW HIRING)

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 is responsible for the global governance, performance, and continuous improvement of CooperSurgical's Corrective and Preventive Action (CAPA) Program. This role ensures CAPA processes are compliant, effective, and consistently executed across the organization while leading a team responsible for CAPA oversight and administration. The position partners cross-functionally to drive timely resolution of quality issues, monitor program effectiveness, support regulatory inspections, and advance continuous improvement throughout the Quality Management System.

Job Summary:

The Manager, Global CAPA is responsible for leading and continuously improving CooperSurgical's global Corrective and Preventive Action (CAPA) Program to ensure compliance with applicable regulatory requirements and quality standards. As the global process owner for CAPA, this role provides oversight of CAPA execution, program performance, effectiveness monitoring, and process governance across all sites and business units.

The Manager partners with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, and other stakeholders to ensure quality issues are appropriately investigated, root causes are identified, corrective actions are effective, and systemic risks are addressed. Through KPI management, trend analysis, inspection readiness activities, and continuous improvement initiatives, this role drives CAPA program effectiveness and supports the overall health of the Quality Management System.

The position leads a team responsible for CAPA oversight and execution support, while serving as a key advisor to Quality Leadership on CAPA performance, emerging quality risks, and opportunities for quality system improvement.

Knowledge, Skills and Abilities:

• Expert knowledge of CAPA systems, root cause analysis methodologies, effectiveness verification, and quality system investigations. 

• Strong understanding of FDA QMSR, ISO 13485, MDSAP, EU MDR, and applicable quality system requirements. 

• Experience leading CAPA programs within a global, regulated medical device environment. 

• Demonstrated ability to analyze quality system data and translate findings into actionable improvement plans. 

• Experience supporting regulatory inspections, notified body audits, and remediation activities. 

• Strong leadership, influencing, and stakeholder management skills. 

• Proficiency with electronic Quality Management Systems (eQMS), including Veeva, TrackWise, MasterControl, or equivalent.

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:

• 8-10+ years of quality experience in a regulated medical device, pharmaceutical, or life sciences industry. 
• 5+ years of direct CAPA, Quality Systems, Compliance, or Quality Engineering experience. 
• 5+ years of leadership experience, including development of technical and professional staff. 
• Experience supporting FDA, MDSAP, notified body, and customer audits.

Education:

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related discipline required.
• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE).

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Our Benefits:

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.

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 place. 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 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.

• Own and maintain the global CAPA Program, including associated procedures, workflows, governance processes, and system requirements. 

• Ensure CAPA processes remain compliant with applicable regulatory requirements and industry standards, including FDA QMSR, ISO 13485, MDSAP, and EU MDR. 

• Establish and maintain standards for CAPA initiation, prioritization, escalation, effectiveness verification, and closure. 

• Serve as the global CAPA process owner and subject matter expert for CAPA-related regulatory expectations and best practices. 

• Ensure inspection-ready documentation and traceability throughout the CAPA lifecycle.

• Provide oversight of CAPA activities across the organization to ensure timely execution, quality of investigations, and sustainable corrective actions. 

• Review and approve significant CAPAs, investigations, and effectiveness strategies, as required. 

• Monitor CAPA program performance and identify opportunities to improve effectiveness, consistency, and cycle time and escalate quality system risks and other CAPA KPIs.

• Ensure recurring issues and adverse trends are appropriately assessed and addressed through the CAPA process.

• Develop and maintain CAPA performance metrics, dashboards, and management review inputs. 

• Analyze program trends to identify systemic quality issues, emerging risks, and opportunities for continuous improvement. 

• Report CAPA program performance, risks, and improvement opportunities to Quality Leadership and senior management. 

• Lead initiatives to improve CAPA process maturity, compliance, efficiency, and user experience.

• Serve as the CAPA lead during regulatory inspections, notified body audits, and internal audits. 

• Coordinate CAPA-related responses to audit observations, inspection findings, and regulatory commitments. 

• Ensure CAPA processes remain inspection-ready through ongoing monitoring and assessment.

• Promote a culture of accountability, continuous improvement, and effective problem-solving.

• Partner with Quality, Regulatory Affairs, Manufacturing, Operations, R&D, Supply Chain, and other functions to drive resolution of systemic quality issues. 

• Support strategic quality initiatives and enterprise quality system improvements. 

• Represent the CAPA Program during management reviews and quality governance forums.

• Perform other duties as assigned.

Travel: This position may require 10-20% domestic and/or international travel.