Senior Global CAPA Engineer – Quality & Compliance Leader

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

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.