Senior Manufacturing Quality Engineer
Core
Lead nonconformance management, CAPA activities, and process validation to ensure compliance and drive continuous improvement in medical device manufacturing.
Role type
Senior Manufacturing Quality Engineer
Builds
compliant medical device manufacturing processes
Domain
Medical Devices / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, CAPA implementation, risk management (PFMEA), statistical process control, process validation (IQ/OQ/PQ), measurement system analysis
Preferred skills
none stated
Technologies
ISO 13485, FDA 21 CFR Part 820, ISO 14971
Responsibilities
Lead nonconformance management and CAPA activities, Partner with manufacturing teams to reduce defect rates, Ensure compliance with regulatory standards, Drive continuous improvement using risk-based methodologies, Support development of inspection strategies, Perform data analysis to evaluate process capability
Seniority
Senior, hands-on IC