Senior Global CAPA Engineer

CooperSurgical, Inc.; Trumbull (CT); On-site; USD 120,000 - 150,000; Full time

Job summary

CooperSurgical is seeking a Sr. Global CAPA Engineer to lead the global CAPA program, providing expert guidance on investigation techniques, root cause analysis, risk evaluation, and corrective action development.

The role partners with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, and other teams to drive continuous improvement and maintain regulatory compliance. The position emphasizes effective CAPA execution, documentation, and trending, ensuring CAPAs are

Qualifications

• Expert guidance on CAPA investigations and RCA.
• Experience with regulatory requirements and quality systems.
• Strong collaboration across functions (QA, Regulatory, Ops).

Responsibilities

• Facilitate complex and high-risk CAPAs and perform quality reviews of CAPA records.
• Analyze CAPA trends and identify opportunities to improve quality system performance.
• Guide CAPA owners on investigation techniques, root cause analysis, and effectiveness verification.
• Ensure CAPAs are executed consistently, effectively, and in compliance with regulatory requirements.

Skills

CAPA

Root Cause Analysis

Risk Evaluation

Investigations

Cross-functional Collaboration

Job description

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.

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)