• Document Control Coordinator

    Tecomet (Woburn, MA)
    …the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. Training includes but is not ... and records to ensure documentation procedures are maintained based on FDA /ISO and Corporate standards and regulations. **ESSENTIAL FUNCTIONS:** + Coordinates the… more
    Tecomet (05/08/25)
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  • Senior Specialist - Regulatory Affairs

    Integra LifeSciences (Braintree, MA)
    …development of US and International regulatory strategies and verification and validation activities for assigned product submissions. + Author draft submissions ... supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports,...Notices, and 180 Day Submissions in accordance with US FDA requirements. + Interact with Regulatory Body personnel with… more
    Integra LifeSciences (03/06/25)
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  • Quality Engineer 2, Design Assurance

    Teleflex (Chelmsford, MA)
    …and execution of Design Controls, Risk Management, Test Method Development and Validation , Design Verification/ Validation for new and existing products. * ... input/output relationships. * Create and support the development and validation of new test methods. * Determine and document...Basic understanding of industry regulations such as ISO13485 and FDA QSR's. * Foster a positive culture of growth,… more
    Teleflex (05/09/25)
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  • Quality Engineer 2

    Hologic (Marlborough, MA)
    …(NPI) and Transfers. + Write, review, and/or approve reports for: Test Method Validation , Design Verification, Design Validation , and Process Validation (IQ, ... of education and experience + Knowledge of ISO 13485, FDA regulations, and cGMP is required. + Computer literacy...+ Computer literacy is required. Must follow all applicable FDA regulations and ISO requirements. _Hologic is an equal… more
    Hologic (05/01/25)
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  • Staff Engineer, Software Design Quality

    Abbott (Burlington, MA)
    …non-medical software, and non-product software + Support software verification and validation activities for new products and software changes in accordance with ... for final review and approval of project deliverables + Support non-product software validation by assessing the need for validation and preparing and/or… more
    Abbott (03/08/25)
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  • Quality Engineer

    Actalent (Newton, MA)
    …implement, and maintain quality management systems (QMS) in compliance with FDA regulations, ISO standards, and other relevant regulatory requirements. + Regulatory ... Ensure that all medical devices meet regulatory requirements and standards, including FDA , ISO 13485, and other applicable regulations. + Risk Management: Conduct… more
    Actalent (05/02/25)
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  • Staff Engineer, Quality Design Assurance

    Integra LifeSciences (Mansfield, MA)
    …+ Draw on experience with root cause analysis, design verification/ validation , statistical methods and analysis, technical specification review, experimental design, ... as well as reliability engineering principles to complete new product development, validation , design transfer and new product introduction in the Neuroscience and… more
    Integra LifeSciences (04/29/25)
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  • Sr Quality Assurance Representative - Digital…

    ThermoFisher Scientific (Cambridge, MA)
    …of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system ... sites, work to support computerized system compliance from system design, validation and verification, release, maintenance, change management, and retirement for… more
    ThermoFisher Scientific (04/26/25)
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  • Research Scientist 1 - Immunochemistry

    Charles River Laboratories (Shrewsbury, MA)
    …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
    Charles River Laboratories (03/04/25)
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  • Quality Control Technician II, Analytical

    Integra LifeSciences (Boston, MA)
    …Quality Control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    Integra LifeSciences (04/16/25)
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