CAPA Engineer
Core
Lead Corrective and Preventive Action (CAPA) investigations and root cause analysis to resolve quality issues, nonconformances, and audit findings in medical device manufacturing.
Role type
Quality Engineering / CAPA Management
Builds
Quality system compliance and regulatory readiness for medical device products
Domain
Medical Device Manufacturing / Quality Systems
Deliverable
dashboards & analysis
Required skills
CAPA management, root cause analysis (5 Whys, Fishbone, DMAIC), risk management, data analysis, quality system regulations, statistical tools
Preferred skills
Medical device industry experience, TrackWise proficiency
Technologies
TrackWise, Microsoft Office
Responsibilities
Lead CAPA investigations from initiation to closure, facilitate cross-functional investigation teams, develop and verify effectiveness of corrective and preventive actions, monitor CAPA metrics and aging, support internal and external regulatory audits
Seniority
Mid-level, hands-on IC