- Cytiva (Miami, FL)
- …Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated ... Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross...value to our lives. Whether it's a health care program or paid time off, our programs contribute to… more
- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European ... GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This...Medical Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well as… more
- Cytiva (Miami, FL)
- …engineering or project engineering role, preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and ... into clear, concise language for a non-technical audience.Working in Pharmaceuticals or Medical Device industryExperience with Veeva & Magic systemsCytiva, a… more
- Beckman Coulter Diagnostics (Miami, FL)
- …with 5+ years of clinical trial experience in vitro diagnostics (IVD), medical device , or healthcare clinical field.Demonstrated agility with processes and ... Diagnostics is responsible for monitoring the in-house blood draw program and coordinating the efforts to add new study...Clinical Affairs Team and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials.… more
- Cytiva (Duncan, SC)
- …control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory requirements and ... Control and Sterility Assurance management.This position reports to the Sr. QA Manager Contamination Control and Sterility Assurance US Region and is part of… more
- Cytiva (Miami, FL)
- …of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... effective design transfers and product launches.This position reports to the QA Senior Manager Site Quality Leader and is part of the Quality and Regulatory Affairs… more
- Hologic (Newark, DE)
- Sr. Program Manager Newark, DE, United States **Senior Program Manager - Medical Device Development** Are you ready to lead groundbreaking ... passion for advancing women's health, and we're looking for a **Senior Program Manager ** to spearhead complex, multi-product initiatives that deliver innovative… more
- US Tech Solutions (San Bruno, CA)
- …issues. **Mandatory:** + 5+ years of experience in program management. + Experience in Medical Device Manufacturing or Software as a Medical Device ... **Responsibilities:** + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring product specifications… more
- Danaher Corporation (Sunnyvale, CA)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Principal Program Manager is responsible for ensuring ... in a molecular in-vitro diagnostic company . The Principal Program Manager leads a cross functional team...of related work experience leading product development in the medical device industry. + Prefer minimum 4+… more
- Fujifilm (Bothell, WA)
- **Position Overview** The Senior Program Manager is responsible for leading the planning, coordination, and execution of product development projects that result ... leadership of the with cross-functional project team and in compliance with QSR820.1 (FDA medical device ) requirements. + Build and lead a Programs team focused… more
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