- Philips (Plymouth, MN)
- **R&D Program Manager - Medical Device NPD (Plymouth, MN)** We are seeking a highly motivated and experienced Program Manager with a background in managing ... experience with a minimum of 7 years in program/project management within the medical device , healthcare, or similarly regulated industry, with proven experience… more
- Capgemini (Minneapolis, MN)
- Role - System Test Engineer ( Medical Device ) Location - Minneapolis MN - Onsite Hire Type - Full Time **About the job you're considering** We are looking 4-8 ... discovered. + Perform review of design, development, and testing of software used in medical device product lines. + Actively working to support Automated Test… more
- 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
- 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 (Minneapolis, MN)
- …(NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high- ... quality , reliable, and safe medical devices that meet or exceed regulatory standards and...Control Charts, & ANOVA; CAPA; and Combination [pharmaceutical and medical device ] Products, ( FDA 21… more
- Abbott (Minnetonka, MN)
- … and TUV regulations, and other relevant clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. Quality ... that are in line with company goals and objectives, mission and vision and FDA /ISO regulations; assures the overall quality of products meet internal and… 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)
- …various government and industry regulations to include FDA QSR 21 CFR 820, EU Medical Device Directive (EU MDD 93/42 EEC), ISO 13485, ISO 9001, and ISO ... (Good Manufacturing Practices) for Class II and Class III medical devices to ensure quality products and...product controls; GMP for Class II and Class III medical devices; FDA QSR 21 CFR 820,… more
- Patterson Companies, Inc. (St. Paul, MN)
- …experience with quality management systems and regulatory compliance in the medical device or related regulated field + Developing working knowledge of ... for maintaining and managing the daily operations of the Patterson Quality Management System. Manages compliance activities with responsibility for results in… more
- Actalent (Minneapolis, MN)
- … quality function. + Minimum of five years of related experience in medical device manufacturing. + Experience with continuous improvement, Lean Six Sigma, or ... Quality Engineer Job Description The Operations Quality...engineering support to US Operations to ensure compliance with FDA regulations. + Act as the first line support… more