- Philips (Plymouth, MN)
- …experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device industry, including 3+ years of experience and a ... Affairs and/or Quality teams. + You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971,… more
- Abbott (Plymouth, MN)
- …is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. As the Senior ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Actalent (Minneapolis, MN)
- …This position requires a deep understanding of embedded systems engineering, medical device regulations, and the technical challenges associated with ... DSP algorithms to enhance image quality. + Ensure adherence to stringent medical device quality systems through meticulous verification, extensive documentation,… more
- ManpowerGroup (St. Paul, MN)
- …+ Strong communication, teamwork, and organizational skills + Experience in medical device industry preferred + Knowledge of risk management , ImV/TMV, ... product development and manufacturing quality activities. This role includes risk management , design verification/validation, process validation, and support… more
- Medtronic (Brooklyn Center, MN)
- …engineering + Recent experience in a regulated industry such as automotive, aerospace, or medical device + Medical device experience strongly preferred ... analysis skills, including SPC + Root cause analysis methodology + Risk Management or CAPA experience + Experience in Automated Optical Inspection Validation… more
- Cognizant (St. Paul, MN)
- …cross-functional teams developing, and supporting information systems in the Medical Device and pharmaceutical manufacturing industries Understand the ... program Awareness of Electronic Lot History Records using Camstar Software for Medical Device / Pharma industries Implement and execute the shopfloor transaction… more
- Xylem (Chaska, MN)
- …approval of risk activities as well as other deliverables as related to medical device projects * Review and approve all Labeling (product, advertising and ... a Science or Engineering field, or equivalent work experience * 5+ years of Medical Device Regulatory Affairs experience, domestic and international * 3 years of… more
- Philips (Plymouth, MN)
- …post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices. + Knowledge of how ... well as quality system compliance. **Your role:** + Ensure Risk Management is effective utilizing feedback from...**You're the right fit if:** + Good understanding of Medical Device QSR, ISO 13485 and ISO… more
- Medtronic (Mounds View, MN)
- …embedded security of regulated or safety critical devices. + Knowledge of the medical device industry. + Experience performing hardware and software penetration ... "outside the box". + Experience facilitating working sessions. + Knowledge in risk management and assessment methodologies, security frameworks and relevant… more
- Danaher Corporation (Chaska, MN)
- …manufacturing environments. + Strong knowledge in quality systems and tools, including risk management , CAPA, APQP, PPAP, FAI, and statistical analysis ... would be a plus if you also possess : + Experience in FDA-regulated or medical device manufacturing environments. + Certifications such as CQE, CQA, Six Sigma,… more