About this role
About the Role Senior CAPA Coordinator providing quality assurance support and oversight for Corrective and Preventive Action activities within the Quality Compliance department. You will mentor cross-functional teams, facilitate CAPA investigations, define root cause, and drive continuous improvement to ensure timely and compliant CAPA execution. What You'll Do
- Provide senior QA support and oversight to CAPA activities, guiding cross-functional teams through the CAPA request and CAPA process
- Mentor teams, facilitate investigations, and help define problem scope and root cause analyses
- Develop and document Effectiveness Check (EC) criteria; perform CAPA Verification of Implementation (VOI) and EC activities
- Process CAPA documentation in electronic systems; act as facilitator for CAPA Review Board as needed; communicate status and action reminders across the organization
- Lead continuous improvement within the CAPA process; update procedures to stay compliant with regulations
- Develop and deliver CAPA System training; mentor junior engineers
- Support Quality Compliance tasks affecting the QMS; analyze new or revised standards and ensure continuous compliance with ISO 13485, EU-MDR, MDSAP, and QMSR
- Assist in external audits as needed (scribe, backroom technical support, file preparation) What We're Looking For
- Strong experience in CAPA management, investigations, root cause analysis, and CAPA closures
- Ability to guide cross-functional teams and manage multiple CAPA projects and timelines
- Knowledge of QMS requirements and applicable standards (ISO 13485, EU-MDR, MDSAP) and regulatory requirements
- Experience with VOI/VOE, EC documentation, and electronic CAPA systems; excellent written and verbal communication
- Ability to mentor junior engineers and train others on CAPA processes Compensation & Benefits
- Salary range: $95K-$120K annually, plus 10% STIP
- Hybrid work arrangement: 1-2 days at home; site-based role in Merrimack, NH