Sr. Quality Engineer
Medtronic, Inc.
Los Angeles, CA
Full-time
Engineering
Posted on October 13, 2019
Medtronic, Inc. Sr. Quality Engineer Sr. Quality Engineer - Risk for Medtronic, Inc. at its facilities located in Northridge, CA. Duties: Plans, coordinates, and executes Medical Device Risk activities to ensure the safety and reliability of Medtronic Mini-Med products from concept to end of life. Masters’ Degree in Biomedical Engineering or related engineering field and 2 years of experience in quality engineering in the medical device industry and 2 years of progressive experience in all of the following: Navigating risk activities to include FMEA including Design FMEA, Process FMEA and Software FMEA, and Design Controls; Navigating ISO quality system ISO13485, ISO 14971, US FDA Quality System Regulation (21 CFR 820), EU Medical Device Directive and relevant international standards; Medical device product development, complaint handling, and vigilance processes; Analyzing production and post-market data to identify changes to product and system risk profile; Facilitating pre-production risk assessments and conducting post-production risk assessments and Issue Impact Assessments (IIAs) for field issues; Owning, improving, and implementing risk-related procedures to match current state-of-the-art industry practices; Supporting manufacturing operations including process changes, design changes, new materials and new component engineering change orders. Apply at www.medtronic.com/careers, Req.19000JEF. Medtronic is an equal opportunity employer committed to cultural diversity in the workplace. All individuals are encouraged to apply.