Eli Lilly and Company seeks a Principal Associate QA - IDM (R3 - R4) to provide quality oversight and support for medical devices and combination products during technical transfer to contract manufacturers. Ensure design meets critical requirements and risks to product quality have been identified, addressed in the design and tested. Verify that equipment is fit for use and ensure manufacturing readiness for prospective contract manufacturers (CM) and suppliers. Provide quality oversight for the technical transfer of medical devices in the eluate portfolio. Support device development reviews to ensure appropriate design for manufacturability. #1-DNI
Position requires a Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field and 5 years of progressively responsible experience in Quality, Technical Services, Product Development, and/or Manufacturing of medical devices. Experience must include a minimum of 5 years of experience with global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, ISO 13485, 14971, 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAI, TGA, ANVISA); 5 years of experience with Quality System elements, devices, design, manufacturing, and validation and their application in a manufacturing environment; 5 years of experience with plastic molding/assembly operations; 5 years of experience with Microsoft applications, Veeva, and TraceWise. Up to 25% domestic travel required. Part-time telecommuting schedule permitted. #1-DNI
Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-103491 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenacre, Corporate Center, Indianapolis, IN 46285.
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