- Kelly Services (Germantown, WI)
- …+ Process supplier and customer change notices. + Serve as manufacturing liaison for quality -related issues. + Approve medical device releases: + Conduct ... with customers on waivers or deviations. + Maintain the Quality Management System (QMS) in compliance with...in a quality engineering role within the medical device manufacturing environment + Understanding of… more
- AbbVie (Pleasanton, CA)
- …have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year of ... drawings & GD&T + performing daily assigned tasks in compliance with FDA's Quality System Regulation (QSR),...MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes… more
- Ricoh Americas Corporation (Indianapolis, IN)
- …Bachelor's degree in a technical field and 3+ years of experience in manufacturing quality operations medical device industry. + ISO 13485 experience ... quality of materials, products, systems, and processes in compliance with 21 CFR 820, ISO 13485, and other...under 21 CFR 820 required + Prior experience with medical qualification and validation protocols for equipment, systems, processes… more
- Lilly (Indianapolis, IN)
- …for people around the world. The Associate Director- Quality - Indianapolis Device Manufacturing Device Quality Control Lab is primarily responsible ... for quality control oversight of the Device Quality Laboratory. **Responsibilities:** + Provide leadership...820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL) + Regulatory inspection… more
- Abbott (Plymouth, MN)
- …activities + Writes and submits intellectual property. + Ensure quality system compliance for medical device development. + Champions design for ... Mechanical / Chemical / Biomedical Engineering + Required minimum years of work experience in medical device R&D - 5+ years with BS, 3+ years with MS or 1+ year… more
- Zimmer Biomet (Englewood, CO)
- …in Engineering or technical discipline and 3 years of related experience + Medical device experience preferred + Process Validation experience preferred + ... innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's... Engineer II has varied responsibilities to assist the Quality team in ensuring compliance to regulations… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jul 10, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety… more
- AbbVie (Branchburg, NJ)
- …the partners. + Inspection & Audit independently assesses compliance and quality of AbbVie R&D's pharmaceutical, device , and combination products GxP ... Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie's Clinical Sciences Development Program - Medical Device consists of three rotations over two years… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and… more
- Merck (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for...launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design,… more
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