- Cole-Parmer (Franklin, MA)
- …Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA Status: Exempt Position Summary: The Senior Manager , Quality and Regulatory Assurance position is responsible ... Job Title: Sr . Manager , Quality and Regulatory Assurance...for the implementation and execution of the Quality program for all products, raw materials, processes and services.… more
- Cardinal Health (Boston, MA)
- …deadlines, and identifies and addresses any emerging issues. In the event of conflict the Program Manager has the power to decide on the outcome (within the ... As a key member of the Cardinal Health Corporate Engineering team, the Sr Project Manager will drive the successful introduction, transfer, and ongoing… more
- AbbVie (Worcester, MA)
- …systems are connected, accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and MHRA requirements. ... We are seeking a result driven and technical oriented Manager - Analytics and Data Integrity to lead site analytics...integrity. + Ensure adherence to regulatory standards (e, g FDA , GxP etc.) + Manage remediation efforts, utilizing risk… more
- Medtronic (Newton, MA)
- …to engineer the extraordinary. Medtronic is seeking a motivated and detail-oriented Sr . Software Tools Engineer to join our Cardiac Ablation Solutions Software team. ... ensuring efficiency, accuracy, and quality throughout the product development lifecycle. The Sr . Software Tools Engineer will an integral member in the Cardiac… more
- Cardinal Health (Boston, MA)
- …integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager , Quality Assurance in quality ... are properly reviewed for quality and documented. **_Job Summary_** The Sr . Specialist, supplier quality management executes quality programs, policies, and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Sr Principal R&D Engineer is responsible for contributing to the ... for new and existing products. + Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other...coverage effective on start date + 24/7 Employee Assistance Program + Free live and on-demand Wellbeing Programs +… more
- Medtronic (Boston, MA)
- …innovation in a more connected, compassionate world. **A Day in the Life** As a Senior Software Test Engineer working in the Seaport District of Boston, MA, you will ... testing tools, and participate in release activities. As a senior member of the Controls Verification team, you will...to Have** + Experience with Medical Product verification and FDA guidance. + Basic understanding of creating test protocols… more
- Fujifilm (Boston, MA)
- …for liaising with key opinion leaders in the Endoscopy space. The role of the Senior Business Development Manager is to understand and define our internal and ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Medtronic (Boston, MA)
- …minimum of 2 years relevant experience. + Experience as a Product Owner or Product Manager of at least 3 years working on complex products. **Nice to Have:** + ... and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and IEC 62304....computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Integra LifeSciences (Mansfield, MA)
- …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... and compliance always. + Participate in audits and other compliance program -related activities. + Executes other duties/responsibilities as assigned by manager… more
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