Senior Lead Specialist, Design Quality Engineer, Coils
Core
Lead compliance strategies and quality activities for MR Coil technologies across design, manufacturing, and service to ensure regulatory adherence and patient safety.
Role type
Senior Lead Specialist, Design Quality Engineer (Medical Devices)
Builds
MR Coil products for GE HealthCare
Domain
Medical Devices / MRI Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), regulatory compliance (21 CFR 820, ISO 13485, MDSAP), internal auditing, CAPA management, root cause analysis, Lean methodologies, design controls, process improvement
Preferred skills
New Product Introduction (NPI), design transfer, production and process controls, installation and servicing, risk management
Technologies
21 CFR 820, ISO 13485, MDSAP
Responsibilities
Lead quality and compliance activities for MR Coil technologies; ensure adherence to QMS and regulatory requirements; represent company to external regulatory agencies; perform internal audits; manage CAPA projects; support product launches and design/manufacturing transfers; apply Lean methodologies to improve processes.
Seniority
Senior, hands-on IC with leadership responsibilities
