Senior Quality Engineer
Core
Develop and maintain quality engineering methodologies and provide support for new product development, manufacturing, and system/services support to ensure products meet internal and external requirements.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Healthcare / Medical Devices / Quality Engineering
Required skills
Process control systems, Six Sigma, Lean Manufacturing, Risk analysis, FDA regulations, GMP, ISO 13485, ISO 14971, Statistical/data analysis, SOP/DWI development, Product verification and validation
Preferred skills
Supervisory experience, Medical device experience, ASQ CQE certification, Cross-division business unit experience
Technologies
Statistical tools, Data analysis software, QMS systems
Responsibilities
Identify and implement effective process control systems; Lead, coach, and mentor non-exempt and entry level personnel; Design and conduct experiments for process optimization; Lead process control and monitoring of CTQ parameters; Lead investigation and resolution of product and process nonconformances; Work with design engineering in product verification and validation; Manage primary contact with Distribution Centers regarding quality issues; Develop and implement Standard Operating Procedures (SOP) and Detailed Work Instructions (DWI).