Quality Engineer
Core
Lead process risk management, nonconformance resolution, and inspection planning for new product introduction and sustaining manufacturing in the medical device industry.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PFMEA, CAPA, statistical methods, metrology, precision measurement, 21CFR820, ISO13485, ISO14971, DOE, SPC, Six Sigma, Lean Manufacturing
Preferred skills
ASQ Quality Engineering Certification
Technologies
None stated
Responsibilities
Lead process risk management (PFMEA), lead evaluation and resolution of product/process nonconformances, lead creation and update of product inspection plans, perform measurement uncertainty analysis, support New Product Introduction with metrology planning, lead process improvement efforts using quality metrics, lead systematic problem-solving methodologies, lead process control and monitoring of CTQ parameters, participate in or lead teams supporting quality decisions, provide leadership as an individual contributor, align with cross-functional partners, manage assigned activities and team members.
Seniority
Senior, hands-on IC
