Senior Global CAPA Engineer — Quality & Compliance

CooperSurgical; Trumbull (CT); 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 is seeking a Sr. Global CAPA Engineer to lead and optimize the CAPA program across the organization, ensuring effective investigations, root cause analysis, and corrective actions. You will work with Quality, Regulatory, Operations, and R&D to verify effectiveness and maintain compliant records.

The role requires 5+ years in regulated industries, ISO 13485/MDR experience, and the ability to coach teams in problem-solving methodologies. Travel up to 20% is anticipated.

Qualifications

• Knowledge of 21 CFR 820, ISO 13485, EU MDR regulatory requirements.
• Experience managing projects at a Global Level in a regulated environment.
• Strong CAPA and quality system experience.
• Ability to lead investigations and root cause analyses.
• Strong technical writing and documentation skills.

Responsibilities

• Provide technical guidance to CAPA owners across all CAPA phases.
• Lead complex, high-risk CAPAs and ensure timely completion.
• Review CAPA records for completeness and compliance.
• Support investigations, root cause analyses, corrective actions, and verifications.
• Conduct CAPA documentation reviews for accuracy and traceability.
• Monitor CAPA performance metrics and trends.
• Identify risks impacting CAPA quality and timelines.
• Support remediation of audit findings and systemic issues.
• Ensure compliance with regulatory requirements and internal procedures.
• Develop management reports and CAPA performance dashboards.

Skills

Quality engineering

CAPA

Regulatory knowledge

Project management

Technical writing

Cross-functional collaboration

English communication

Education

Bachelor's degree in biomedical engineering or related technical discipline

ASQ Certified Quality Engineer (CQE) preferred

Project Management Certifications preferred

Tools

Microsoft Office

Job description

CooperSurgical is seeking a Sr. Global CAPA Engineer to lead and optimize the CAPA program across the organization, ensuring effective investigations, root cause analysis, and corrective actions. You will work with Quality, Regulatory, Operations, and R&D to verify effectiveness and maintain compliant records.

The role requires 5+ years in regulated industries, ISO 13485/MDR experience, and the ability to coach teams in problem-solving methodologies. Travel up to 20% is anticipated.