Quality Engineer 2
Core
Leads quality planning and ensures product quality from development through market release for implantable medical devices.
Role type
Quality Engineer II (Regulated Medical Devices)
Builds
New product launches compliant with FDA and ISO standards
Domain
Medical Devices / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, root cause analysis, CAPA, FMEA, DOE, statistical methods, trend analysis, design control, verification/validation, design transfer, regulatory compliance (FDA 21 CFR 820, ISO 13485, ISO 14971), technical writing, problem-solving
Preferred skills
Implantable medical device experience
Technologies
SAP/ERP, Microsoft Office (advanced Excel), Minitab, GD&T
Responsibilities
Represent Quality on new product development teams for design control, verification/validation, and risk management; Support engineering and manufacturing with validation activities; Train cross-functional teams on quality regulations; Ensure compliant Design History Files and Engineering Change Orders; Lead product risk management activities; Process Non-Conforming Material Reports; Develop and maintain final inspection plans; Review verification/validation protocols for cGMP compliance; Drive continuous improvement in design and development processes
Seniority
Mid-level, hands-on IC