Global CAPA Engineer — Quality & Continuous Improvement

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

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