- Cytiva (Pensacola, FL)
- … Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated manufacturing ... do: Quality Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance,… more
- Beckman Coulter Diagnostics (Miami, FL)
- …of experience, preferably in areas of medical devices, engineering, or quality assurance.Strong knowledge of Quality , Regulatory compliance, and ... standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485,...designations are not required but training and certificates in quality or regulatory affairs would be a… more
- Cytiva (Miami, FL)
- …Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... Quality Leader and is part of the Quality and Regulatory Affairs Team located in...previous experience in:Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.Proficiency with… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949#LI-OnsiteJoin our ... about the Danaher Business System which makes everything possible.The Senior Supplier Quality Engineer (m/f/d) for Cytiva is responsible to manage supplier defects,… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent ... about the Danaher Business System which makes everything possible.The Senior Supplier Quality Engineer for Cytiva is responsible to manage supplier defects, be… more
- Cytiva (Miami, FL)
- …manufacturing or medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA, ISO 13485, Good Manufacturing ... manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment.… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …of experience in a regulated environment or GMP compliant environment (Pharmaceutical, Medical Device , OTC Drug, Cosmetic, etc.)Experience with basic statistical ... in support of the stability program, including review and implementation of regulatory requirements for the stability program.Coordinate with Quality Control… more
- Takeda Pharmaceuticals (Boston, MA)
- …with colleagues in Medical Safety, LOCs, Global Clinical Development, Global Regulatory Affairs, Device Quality , PV Compliance etc. **ACCOUNTABILITIES:** ... both internal and external stakeholders, including the Medical Safety, Device Quality Assurance, and Regulatory Affairs, Notified Bodies and Health… more
- Eurofins (Boston, MA)
- …+ Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management. + Foster a culture ... to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality assurance processes. This role… more
- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... to advance patient outcomes and set new standards of care. **SUMMARY** The Quality Control Technician II will be responsible for performing Quality Control… more
- Cook Medical (Winston Salem, NC)
- …or- BS degree in same with 3 years relevant experience- Knowledge of medical device quality and regulatory systems - Ability to work independently and ... document design and/or process changes required for the maintenance of released medical devices. Responsibilities - Serve as technical and project leader for product… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies ... Global Device Sub team to ensure that regulatory device labeling requirements are met for...and/or high complexity products (including combination, Software as a Medical Device , and standalone medical … more
- Merck (North Wales, PA)
- …Resolve project issues through collaboration with the team and escalation to the DQR ( Device Quality and Regulatory ) leadership team as appropriate. + ... post-approval submissions/variations, according to defined timelines. + Provide detailed, global regulatory assessments for changes to device and drug- device… more
- Catalent Pharma Solutions (Kansas City, MO)
- …+ 10+ years of relevant experience in pharmaceutical or medical device manufacturing, quality or regulatory , general business management, technical ... development, analytical research and development, project scale-up, product manufacturing, quality , validations, and regulatory + Experienced contract negotiator… more
- GE HealthCare (Cleveland, OH)
- …teams with documentation creation and updates; build your knowledge of medical device quality and regulatory guidelines + Develop and maintain ... at least 4 years of prior experience in technical writing, preferably in the medical industry or a related area + Aptitude to develop clinical and anatomical… more
- Kelly Services (Valencia, CA)
- …with business stakeholders within a cross-functional matrix environment. * 5+ years Class III Medical Device Company in Regulatory Affairs. * Experience with ... * **Product Labeling:** Collaborate cross functionally to ensure compliance with global medical device labeling regulations by overseeing the creation and… more
- Organon & Co. (Jersey City, NJ)
- …and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( ... cGMP and quality issues related to pure medical devices and the device constituent of... regulatory agency inspections with focus on relevant device regulations and Quality system requirements. +… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the ... IL and report directly into the Senior Manager of Medical Device Quality . + Leads...app launches and market expansions. + SaMD/SiMD SME for regulatory / notified body inspections as needed + Lead… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's ... Assurance group and reports to the Senior Manager, Medical Device External Quality . The...internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality … more
- Pentax Medical (Montvale, NJ)
- …benefits program and generous Paid Time Off and Holiday policy. Want More INFO? The Medical Device , Senior Quality Engineer will lead and implement ... determining root causes and effectively implement the remediations. Responsibilities of Medical Device , Senior Quality Engineer + Utilizing… more
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