Overview In this role you will support quality-system activities within a regulated medical-device environment. You will lead CAPA and Nonconformance investigations, apply structured problem-solving, and ensure documentation and records are inspection-ready. You'll collaborate with cross-functional teams to collect evidence, drive root-cause analysis, and implement corrective actions. This position offers a hands-on opportunity to improve quality processes and ensure regulatory compliance at scale.
Responsibilities- Manage and execute CAPA and NC investigations per procedures and medical-device regulations
- Apply problem-solving and root-cause analysis to identify underlying causes
- Conduct risk-based assessments with objective evidence and proper documentation
- Collaborate with investigation owners, process owners, SMEs, and cross-functional teams
- Facilitate investigation follow-up meetings and document decisions, actions, risks, and escalations
- Monitor investigation status, milestones, overdue actions, risks, and escalation needs
- Maintain accurate, complete, and inspection-ready CAPA/NC/investigation records in the eQMS
- Track milestones, commitments, and due dates to support timely closure
- Enter, update, review, route, and maintain quality records in the eQMS
- Support quality-system activities, audits, and inspection-readiness initiatives
- Coordinate across multiple investigations and quality-system deliverables
- Ensure activities comply with procedures, quality policies, and regulations
- Identify recurring quality issues and opportunities for process improvement
- Collaborate with Quality, Manufacturing, Engineering, Operations, Regulatory, and other teams
Key requirements- 3+ years in Quality Engineering, Quality Systems, Quality Assurance, or related role in the medical-device industry
- Hands-on experience managing CAPA and NC investigations in a regulated environment
- Experience leading investigations through containment, issue definition, data collection, root-cause analysis, corrections, and closure
- Bachelor in Engineering, Life Sciences, Quality, or related technical discipline
- Preferred: degree in Biomedical, Mechanical, Electrical, Chemical, Industrial Engineering or related field
- cross-functional collaboration
- strong written and verbal communication
- problem-solving mindset
- CAPA and NC management
- root-cause analysis methodologies
- risk-based assessment
