- J&J Family of Companies (Minneapolis, MN)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... + Must not be debarred by FDA for work in any Medical Device business. + Ability to work in a fast-paced environment while managing multiple priorities.… more
- 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
- 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
- Medtronic (Mounds View, 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