- Hologic (Newark, DE)
- …and resource planning. + ** Quality Management Systems:** Familiarity with ISO and FDA regulations for medical device design and development. + ... processes. + Familiarity with **ISO and FDA quality systems regulations** , especially for medical device design and development cycles. + Prior… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …equivalent education and relevant experience. **Knowledge and Skills:** + Working knowledge of the FDA medical device quality system regulations and ... **Job Description Summary** The Staff Quality System Specialist I is accountable for support...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education and relevant experience. **Knowledge and Key Skills:** + Working knowledge of the FDA medical device quality system regulations and ... **Job Description Summary** The Sr. Quality System Specialist is accountable for support of...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- J&J Family of Companies (Santa Clara, CA)
- …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. + Establishes and maintains relationships with customers, hospitals, and physicians.… more
- J&J Family of Companies (Albany, NY)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's license. + Operate as a team and/or… more
- Cedars-Sinai (Los Angeles, CA)
- …years of experience using 3D model software preferred + Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO ... and full end-to-end integration tests, when it applies; Supports quality insurance effort to gain user acceptance. 4. Delivery:...Team** Cedars-Sinai is one of the largest nonprofit academic medical centers in the US, with 886 licensed beds,… more
- Sanofi Group (Framingham, MA)
- …years) with a minimum of 15 years relevant experience in the pharmaceutical, biotech, medical device , or related industries. + Extensive knowledge of Quality ... **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA... Quality Council to facilitate sharing of US FDA inspection findings and best practices across entities, M&S… more
- Hologic (Newark, DE)
- …to commercialization. + **Regulatory Standards:** Familiarity with ISO and FDA quality systems regulations and medical device design and development ... Experience:** + Experienced with ISO and FDA quality systems regulations. + Prior experience in medical... quality systems regulations. + Prior experience in medical device design and development cycles. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Wolters Kluwer (Chicago, IL)
- …to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA Class II medical device experience, focused on software as a medical ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities… more
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