- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …+ Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment. + Strong working knowledge of ... components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will… more
- TE Connectivity (Plymouth, MN)
- …experience is required. **Key Requirements** * Working knowledge of FDA /ISO/MDD Quality systems for Medical Device companies. * Experience within ... System. The focus of the role is to supply high- quality medical devices and components to deliver...as Quality Engineer is an advantage. * Quality experience in component and device manufacturing… more
- Philips (Plymouth, MN)
- …working in Regulatory Affairs and Quality / Quality Operations within the FDA regulated Medical Device industry, including 3+ years of experience ... and/or Quality teams. + You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21… more
- Medtronic (Fridley, MN)
- …applying principles of safety risk management. + General working knowledge of applicable global medical device regulations, including FDA CFR 21, EU MDR, ISO ... a clinician advocate and voice for the patient, championing the optimization of medical device safety throughout the product lifecycle. This position supports… more
- Abbott (St. Paul, MN)
- …and demonstrated use of Quality tools/methodologies, statistical/data analysis + Prior medical device experience preferred + Working knowledge of FDA ... colleagues serve people in more than 160 countries. **Development Quality Engineer I** **Working at Abbott** At Abbott, you...location in St. Paul, MN in the Structural Heart Medical Device division. Our business purpose is… more
- Philips (Plymouth, MN)
- …and execution to drive continuous quality improvements in the design of Medical Device products and systems to world-class levels, in close, cross-functional ... The Senior Program Manager-Design Quality , Products & Systems is responsible for the...You've acquired a minimum of 12+ years' experience withing FDA regulated medical device /systems product… more
- 3M (Maplewood, MN)
- …Here, you will make an impact by: + Leading the development and implementation of global Medical Device Quality Processes for 3M + Leading Global Quality ... military environment + Two (2) years of experience in Quality System in Medical Device ...management system experience such as Food and Drug Administration ( FDA ) Quality System Regulation (QSR) and/or International… more
- CAI (Plymouth, MN)
- …detailed work instructions, specifications, and FDA regulations + Operate specialized medical device assembly equipment and tools safely and efficiently + ... measuring and counting components + Commitment to safety and quality standards in medical device ...assembly or related healthcare product manufacturing + Familiarity with FDA regulations and ISO 13485 standards for medical… more
- Abbott (Plymouth, MN)
- …help of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with ... ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Medtronic (Minneapolis, MN)
- … devices + Experience with regulatory support of clinical trials + Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), ... requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions....2 years of experience in regulatory affairs in the medical device industry + Or advanced degree… more
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