Senior CAPA Quality Assurance Coordinator

About the Role Provide Senior Quality Assurance level support and oversight to CAPA activities and other activities within the Quality Compliance department. Mentor cross-functional teams and facilitate activities to ensure effective and timely CAPAs. Drive continuous improvement activities in a hybrid office environment in Merrimack, NH.

What You'll Do

• Provide senior level QA support and oversight to CAPA activities, guiding cross-functional teams through the CAPA request/CAPA process
• Mentor cross-functional teams, facilitate investigations and root cause analyses, and ensure CAPA documents meet procedures and regulations
• Manage CAPA timelines, VOI (Verification of Implementation) and EC (Effectivity Check) activities, update procedures, and train CAPA system users
• Serve as facilitator/delegate for CAPA Review Board; communicate actions and reminders across organization
• Support Quality Management System improvements aligned with ISO 13485, FDA requirements, MDSAP, and QMSR; assist external audits as needed

What We're Looking For

• Bachelor's degree in engineering or science or equivalent experience
• Minimum 3 years of CAPA and root cause investigation experience
• Minimum 3 years of quality/regulatory experience in medical device or highly regulated industry
• Strong communication, organization, attention to detail, and root cause analysis skills
• Knowledge of CAPA, NCR, supplier controls, process controls, design controls, verification & validation, and risk management; knowledge of ISO 13485 and FDA requirements
• Proficient with MS Office and data analysis tools
• Ability to manage multiple tasks and deliverables; experience mentoring junior engineers

Compensation & Benefits

• Salary range: $95,000-$120,000 annually, plus 10% STIP
• Hybrid work arrangement; benefits include Health, Dental, Vision, 401k with company match, PTO, Wellness program, Life Insurance, Disability, FSA, Commuter Benefits, Parental and Caregiver Leave, Tuition Reimbursement
• Getinge is an equal opportunity employer