- Nanobiosym, Inc. (Cambridge, MA)
- …lifecycle: Specification, architecture, circuit design, simulation, schematic capture, prototyping, validation , and release to manufacturing. + Lead PCB design and ... hardware and driver requirements. + Design and build test fixtures for hardware validation and functional testing. + Support regulatory and quality processes with a… more
- Cardinal Health (Mansfield, MA)
- …or testing environment, preferred + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory ... + Working knowledge of regulatory guidelines of analytical method verification, validation , and method transfer, preferred + Experience with investigations of Out… more
- Wolters Kluwer (Waltham, MA)
- …in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities focused on 21 CFR 820, ISO ... Resolution** + Manage and guide system testing activities, including verification and validation . + Lead resolution of quality issues with on-market device software;… more
- Olympus Corporation of the Americas (Westborough, MA)
- …design inputs, product design implementation, verification testing and supporting design validation studies. The ideal candidate is a hands-on technical leader with ... User and Product Requirements. + Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements and… more
- AbbVie (Worcester, MA)
- …+ Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required. + Experience with FDA and ... on a global scale. + Oversee the development and validation of analytical methods for new product introductions (NPIs),...the integrity and accuracy of raw data used in validation processes and Test Method Transfers (TMTs) within our… more
- Teleflex (Mansfield, MA)
- …nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification ... * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests *...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more
- ThermoFisher Scientific (Boston, MA)
- …is highly desirable. + Demonstrated experience in developing and designing method transfer and validation studies per ICH and FDA guidelines is highly desired. + ... review technical documents such as method development reports, method validation protocols, bridging, comparability and technical transfer protocols and reports.… more
- ThermoFisher Scientific (Plainville, MA)
- …testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/ validation of analytical methods for support of cGMP manufacturing, ... and the transfer and validation of assay methods from clients and/or Assay Development...environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other regulatory authorities required.… more
- Hologic (Marlborough, MA)
- …Consulted during product development or transfers (including acquisitions), validation , verification, and clinical preparation as applicable. + **Collaboration:** ... Engineering. + 3-5 years of experience + Experienced with FDA -Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO… more
- Hologic (Marlborough, MA)
- …lifecycle, with a focus on software risk management. + Support validation , verification, and clinical preparation activities as required during product development ... **Skills:** + Deep technical knowledge of **SaMD** , including regulatory requirements such as FDA 21 CFR Part 820 (Design Control), ISO 13485, ISO 14971, and IEC… more
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