• Sr. Software Quality Engineer

    Fresenius Medical Center (Lawrence, MA)
    …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and working remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
    Fresenius Medical Center (06/14/25)
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  • Senior Quality Compliance Specialist…

    Integra LifeSciences (Braintree, MA)
    …2025. + Adequate knowledge of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven ... what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance… more
    Integra LifeSciences (08/08/25)
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  • Sr. Operations Manager

    Abbott (Westford, MA)
    …+ Manufacturing experience with companies engaged in the manufacture of high quality , FDA regulated products. + Proven leadership skills, results oriented, ... meet new product introduction schedules all while enhancing product quality and meeting all compliance requirements. **MAIN RESPONSIBILITIES** + Develop,… more
    Abbott (06/24/25)
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  • Principal Quality Assurance Engineer

    Hologic (Marlborough, MA)
    quality , we want to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + ... Principal Quality Assurance Engineer Marlborough, MA, United States Louisville,...States Louisville, CO, United States Are you an experienced quality assurance professional ready to take your career to… more
    Hologic (08/26/25)
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  • Quality Assurance Engineer 1

    Teleflex (Mansfield, MA)
    …reliability. 2. Assists in ensuring the manufacturing processes comply with regulatory and quality system standards, including FDA , ISO 13485, and other relevant ... Quality Assurance Engineer 1 **Date:** Aug 22, 2025...driven by our purpose to improve the health and quality of people's lives. Through our vision to become… more
    Teleflex (08/23/25)
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  • Quality Engineer- Products and Systems

    Philips (Cambridge, MA)
    …right fit if:** + You have a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a ... The Quality Engineer-Products and Systems is a key member...a key member of our Sleep & Respiratory Care, Quality organization, accountable for ensuring our Sleep & Respiratory… more
    Philips (07/04/25)
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  • Senior Regulatory Affairs Specialist

    Philips (Cambridge, MA)
    …and EU MDR Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate ... preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government agencies. Ensure regulatory submissions are… more
    Philips (08/29/25)
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  • Sr. QA Specialist, Operations

    Catalent Pharma Solutions (Chelsea, MA)
    …Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; Analyze ... records; Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; and… more
    Catalent Pharma Solutions (07/24/25)
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  • Quality Control Technician II, Analytical

    Integra LifeSciences (Boston, MA)
    …or other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. ... new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    Integra LifeSciences (07/31/25)
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  • Senior Regulatory Affairs Specialist

    Fresenius Medical Center (Lexington, MA)
    …documentation for EU Notified Body submissions; * Working with ISO13485 and FDA Quality Management System requirements (QSR); * Participating in Internal ... for NxStage Medical, Inc. products. Will provide regulatory input into key quality system processes such as Design Reviews and Engineering Change Orders. Specific… more
    Fresenius Medical Center (08/20/25)
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