Senior Global CAPA Engineer

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 business unit of CooperCompanies(Nasdaq: COO) were driven by a unified purpose of helping people 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 Sr. Global CAPA Engineer serves as a subject matter expert for the Global Corrective and Preventive Action (CAPA) Program providing technical leadership facilitation and guidance to ensure effective investigation root cause analysis corrective action implementation and effectiveness verification across CooperSurgical.

This role partners with Quality Regulatory Affairs Operations Manufacturing R&D Supply Chain and other functional teams to support the timely execution of CAPAs strengthen problem-solving capabilities and drive continuous improvement across the organization.

Job Summary:

The Sr. Global CAPA Engineer is responsible for supporting the execution and effectiveness of CooperSurgicals Global CAPA Program. This role provides expert guidance to CAPA owners on investigation techniques root cause analysis risk evaluation corrective action development effectiveness verification and documentation requirements.

The Sr. Global CAPA Engineer facilitates complex and high-risk CAPAs performs quality reviews of CAPA records analyzes CAPA trends and identifies opportunities to improve quality system performance. Working closely with cross-functional stakeholders this role helps ensure CAPAs are executed consistently effectively and in compliance with applicable regulatory requirements and company procedures.

Provide technical guidance and support to CAPA owners throughout all phases of the CAPA process.
Facilitate complex high-risk and cross-functional CAPAs to ensure timely progression and successful completion.
Review CAPA records for completeness scientific rigor and compliance with established procedures.
Support investigation activities root cause analysis corrective action planning and effectiveness verification.
Conduct quality reviews of CAPA documentation to ensure records are complete accurate and inspection ready.
Identify and escalate risks that may impact CAPA quality timelines or regulatory compliance.
Support remediation activities related to audit observations inspection findings quality events and systemic issues.
Ensure CAPA activities comply with internal procedures and applicable regulatory requirements.
Monitor CAPA performance metrics aging and effectiveness trends.
Analyze data to identify recurring issues systemic trends and opportunities for improvement.
Support development of management reporting dashboards and CAPA performance reviews.
Recommend process improvements that enhance CAPA effectiveness and quality system maturity.
Coach CAPA owners and cross-functional teams on root cause analysis investigation methodologies corrective action planning and effectiveness verification.
Deliver CAPA-related training and onboarding sessions.
Perform other duties as assigned.

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

Knowledge Skills and Abilities:

• Knowledge of 21 CFR 820 ISO 13485 EU MDR regulatory requirements.
• Experience managing projects at a Global Level in a regulated environment.
• Six Sigma Green Belt or above
• Strong decision-making skills ability to influence and collaborate with cross-functional teams
• Strong technical writing skills
• Ability to provide critical review and feedback on quality records
• Ability to read and interpret technical and regulatory documentation.
• Proficient in Microsoft Office applications (Word Excel PowerPoint).
• Effective written and verbal communication skills (English).
• Ability to work independently and collaboratively across global cross-functional teams in a regulated environment.

• Ability to work in a fast-paced setting with shifting priorities while maintaining attention to detail and compliance standards.

Work Environment:

• Primarily office-based with regular use of computer systems and virtual collaboration tools

Experience:

• 5 years of experience in medical device pharmaceutical biologics or other regulated industries.
• 3 years of direct CAPA quality engineering quality systems or compliance experience.
• Demonstrated experience leading complex investigations and root cause analyses.
• Working knowledge of FDA QMSR ISO 13485 MDSAP and EU MDR requirements.

Education:

• Bachelors degree in biomedical engineering or related technical discipline.

• ASQ Certified Quality Engineer (CQE) preferred.

• Project Management Certifications 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 at 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 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 $100000.00 - $125000.00. The actual 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.