, validation testing, and Gage R&R studies. Mentor junior quality staff and provide training as needed. Qualifications... software, and hardware systems. Experience with ISO 13485, ISO 14971, FDA QSR, IEC 60601, and related standards. Proficiency...
IEC 60601 Experience with reliability testing Demonstrated use of Quality tools/methodologies Strong written/verbal... Previous R&D experience Strong knowledge of QSR and ISO standards Medical device experience ASQ certification Requisition...
and is also a certified CAR-T center for Novartis, Kite and BMS. FACT Accredited and Immune Effector Cell (IEC) program that performs... time Job Requisition ID: R-47878 We are an equal employment opportunity employer without regard to a person’s race...
and/or standards knowledge to be considered a domain expert (SME) that can be assigned and work independently on long lead R&D projects... status and test results to R&D client, sales personnel, and management throughout testing. Provide ongoing support...
in healthcare systems. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives..., or MBA 5+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development, regulatory...
, and suppliers. Mentor engineers and leaders across R&D, New Product Development, and Operations to build and maintain a robust.... Proficiency in 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, ISO 27001, and EU MDR compliance frameworks...
of all performed procedures in assisting in implementation of ISO / IEC 17025:2005 in the laboratory Maintain the good laboratory... that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory...
of all performed procedures in assisting in implementation of ISO / IEC 17025:2005 in the laboratory Maintain the good laboratory... that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory...
about improving patient outcomes across our increasing and wide range of complex systems-based products. As part of the R&D team..., MA office at least three days per week. Your responsibilities will include: Act as an R&D Technical Lead responsible...
is responsible for leading R&D efforts for all medical fiber products, with a strong emphasis on innovation, reliability... and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825...