Senior Global CAPA Engineer

CooperCompanies•Trumbull, CT

6d•Onsite

About The Position

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. 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.

Requirements

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.
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.
Bachelor's degree in biomedical engineering or related technical discipline.

Nice To Haves

ASQ Certified Quality Engineer (CQE) preferred.
Project Management Certifications preferred.

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 escalate 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.