- Cepheid (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Director, Clinical Quality and Compliance reporting to the Sr Director of Clinical ... of the job include:Bachelor's degree in science with 14+ years of clinical quality /GCP experience within the device industry OR Master's degree in science… more
- Beckman Coulter Diagnostics (Miami, FL)
- …and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical ... Board (CRB). This position is part of the Global Quality System and Compliance Group located in...Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well as all other applicable… more
- Cepheid (Miami, FL)
- …(IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities ... to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the Quality … more
- Cytiva (Miami, FL)
- …if you also possess previous experience in:Life Science, Pharmaceutical, Medical Device or Biopharma manufacturing environments.Analytical and problem-solving ... instructions and cross train as a backup for other QA members.Participate in quality walks and internal audits to ensure compliance with industry standards.Who… more
- Beckman Coulter Life Sciences (Miami, FL)
- …required.BS+7 or MS+4 years' experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), ... procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance .The essential requirements of the job include:Degree… 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)
- …control testing, and sterility assurance processes in a highly regulated medical device environment.This role involves conducting laboratory analyses, ... 14644, sterility processes, and cGMP (current Good Manufacturing Practices) in medical device product manufacturing.Experience with Water, Endotoxin, Bioburden,… more
- Raytheon (Tucson, AZ)
- …complex systems. Our precision software and firmware integrate operating systems, device drivers, networking, and control software to bring together sensor, ... software for edge or embedded devices and/or subsystems (like telecom, medical , IoT, automotive, or robotics) where hardware operation, time critical function,… more
- Cytiva (Miami, FL)
- …product lifecycle management systems, in biotech, pharma, drug product, or medical device document control experience preferredStrong foundational knowledge in ... evaluation of internal controls, and maintenance of documentation as related to compliance with internal and external quality and regulatory standards. Assist… more
- Beckman Coulter Diagnostics (Miami, FL)
- …a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this ... Validation Plan and support of the MVP strategies.This position is part of the Quality Assurance - Validation department located in Chaska, MN and will be on-site.… more
- Brady Corporation (Milwaukee, WI)
- …(SOPs), Quality Manual, Quality Policies, and related procedures, ensuring compliance with applicable medical device regulations. + Support New ... 3-5 years of experience in regulatory affairs, compliance , or quality in the medical device industry. + Experience working with cross-functional teams,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance : engage/liaise with medical ... possible, together. **Job Description** **Job Functions:** + Accountable for end-to-end quality compliance of the assigned product/program, which include but… more
- Abbott (Barceloneta, PR)
- …in engineering discipline + 2 years of experience in Quality and/or Compliance , preferably in medical device industry **Preferred Qualifications** + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Organon & Co. (Jersey City, NJ)
- …of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( Medical ... Participate on Organon teams supporting cGMP and quality issues related to pure medical devices and the device constituent of a combination product. + Work… 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 ... External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality . The role will be based out of Lake… more
- Sanofi Group (Cambridge, MA)
- …will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of ... Compliance of SaMD Products:** + Represent Digital Device Quality Engineering on cross-functional teams and...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Amgen (Cambridge, MA)
- …transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** Let's ... between risk (Use and Functional) and Requirements + Ensure compliance /closure of Regulatory and Quality requirements before...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Pentax Medical (Montvale, NJ)
- …in effective communication with cross functional teams for better alignment Requirements of Medical Device , Senior Quality Engineer: + Bachelor's Degree or ... Manager, Production/Manufacturing Why JOIN Us? We are an established medical device leader that is preparing for...employee engagement + Exceptional attention to service, detail, and quality + Familiarity with PENTAX Medical products… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: May 13, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety… more
- PCI Pharma Services (Bedford, NH)
- …pioneer and shape the future of PCI. The **QA Operations Specialist I - Medical Device Floor Support** is responsible for providing QA support of Manufacturing ... and Visual Inspection activities for clinical and commercial medical device products in a GMP facility. The work scope includes on-the-floor Quality … more
