Senior Quality Engineer
Core
Developing and maintaining quality engineering methodologies to support new product development, manufacturing, and system/services support within the medical device industry.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production medical devices and components
Domain
Healthcare / Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process control systems, Six Sigma, Lean Manufacturing, Risk analysis, Protocol writing, Statistical/data analysis, FDA regulations, GMP, ISO 13485, ISO 14971
Preferred skills
Supervisory experience, Medical device experience, ASQ CQE certification, Cross-division business unit experience
Technologies
Statistical tools, Data analysis software
Responsibilities
Identify and implement effective process control systems, Lead and coach entry-level personnel, Design and conduct experiments for process optimization, Lead process control and monitoring of CTQ parameters, Lead investigation and resolution of product nonconformances, Develop and implement Standard Operating Procedures (SOP) and Detailed Work Instructions (DWI), Manage quality issues with Distribution Centers, Support product verification and validation with design engineering
Seniority
Senior, hands-on IC with leadership responsibilities
