Senior Global CAPA Engineer

CooperSurgical; Livingston (NJ); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical seeks an experienced Sr. Global CAPA Engineer to lead the Global CAPA Program. You will guide CAPA owners on investigation techniques, root cause analysis, risk evaluation, corrective action development, and effectiveness verification, ensuring regulatory compliance across functions.

Responsibilities include facilitating complex CAPAs, reviewing records for rigor, and driving improvements across Quality, Regulatory, Operations, and R&D. Travel up to 20% may be required.

Qualifications

• Knowledge of FDA QMSR, ISO 13485, EU MDR requirements.
• Experience leading global CAPA projects in a regulated environment.
• Six Sigma Green Belt or above.

Responsibilities

• Provide technical guidance to CAPA owners across all CAPA phases.
• Facilitate high-risk, cross-functional CAPAs to ensure timely completion.
• Review CAPA records for completeness and compliance.
• Support investigations, root cause analysis, corrective action planning, and effectiveness verification.
• Develop management reports and CAPA performance dashboards.

Skills

Regulatory knowledge

CAPA leadership

Root cause analysis

Technical writing

Cross-functional collaboration

Microsoft Office

English communication

Education

Bachelor's degree in Biomedical Engineering or related

ASQ CQE preferred

Project Management Certification preferred

Tools

CQE (certification)

Job description

Job Description

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 business unit of CooperCompanies (Nasdaq: COO) , we’re driven by a unified purpose of helping people 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.

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 business unit of CooperCompanies (Nasdaq: COO) , we’re driven by a unified purpose of helping people 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 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 CooperSurgical's 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.

Responsibilities

• 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 elevate 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.

Qualifications

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

• Bachelor's degree in biomedical engineering or related technical discipline.
• ASQ Certified Quality Engineer (CQE) preferred.
• Project Management Certifications preferred.

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.

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 $100,000.00 - $125,000.00. 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.