Engineer, Quality Assurance
Core
Provide quality engineering support in quality assurance, control, and preventative activities to ensure compliance with regulations and standards while improving internal products and processes.
Role type
Quality Assurance Engineer (Manufacturing)
Builds
Internal manufacturing processes and product quality compliance
Domain
Medical device manufacturing
Required skills
root cause analysis, non-conformance management, CAPA management, supplier quality management, change management assessment, KPI monitoring, Human Factor practices, procedure development, manufacturing process improvement
Preferred skills
BSc/B.Eng in science or engineering, 0+ years in manufacturing environment
Technologies
None stated
Responsibilities
Manage timely closure of internal and supplier non-conformances; lead root cause investigation and implementation of CAPAs; disposition non-conforming product within MRB; communicate with suppliers regarding non-conformances; engage in development and improvement of internal manufacturing processes; perform critical assessment of proposed change management activities; maintain KPIs for monitoring process and product quality; support execution and analysis of manufacturing related complaints and product field actions; advocate Human Factor practices; collaborate on supplier part certification opportunities