• Senior Staff, Software Quality Assurance Engineer

    Stryker (Portage, MI)
    …audits. + Support internal and external SOC2 audits + Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and ... with R&D software development teams to guide them through internal quality system processes and ensure compliance with internal procedures and regulatory standards… more
    Stryker (07/16/25)
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  • Associate Director, Drug Product, Manufacturing…

    BeOne Medicines (Pennington, NJ)
    …+ Health Authority Interaction/Audits + OE and/or LEAN Methodologies + Distributed Control system / Control Systems + Deviation Assessments / Investigations + ... dedicated gowns, depending on area. + Work with hazardous materials and chemicals. ** Computer Skills:** Familiarity with computer -based systems . Word, Excel,… more
    BeOne Medicines (09/18/25)
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  • Scientist I

    Abbott (San Diego, CA)
    …to the development, implementation and effectiveness of the Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Understands ... clear and accurate records of experiments in a laboratory notebook and engineering/ validation reports. + Generate and present projects, both in depth and high… more
    Abbott (10/01/25)
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  • Associate Quality Engineer - Design

    Zimmer Biomet (Englewood, CO)
    … Systems (QMS) and procedures * Preferred Verification and Validation experience * Knowledge in Machining methodologies preferrable (Titanium and Cobalt ... that has emphasis on developing and maintaining Paragon 28's quality system and related quality activities specifically relating to the day-to-day production,… more
    Zimmer Biomet (10/02/25)
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  • Lead Software Design Assurance Engineer

    Hologic (Newark, DE)
    …your expertise in design control, risk management, software development, and quality systems to ensure our medical devices, particularly those involving Software as ... and execution of design assurance activities, including risk management, verification, and validation . + Serve as a technical mentor to junior engineers, providing… more
    Hologic (09/16/25)
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  • Exec Director, Head of Digital Quality

    Gilead Sciences, Inc. (Santa Monica, CA)
    …software development methodologies * Quality & Compliance Expertise: Mastery of GMP, quality systems , Computer Validation and Data Integrity * Digital ... systems . * Ensure compliance with global regulatory requirements ( FDA , EMA, ICH, GDPR, 21 CFR Part 11). *...GxP digital Compliance (CSV, Data Integrity etc.) * Oversee validation lifecycle for systems such as Veeva… more
    Gilead Sciences, Inc. (10/02/25)
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  • QA Product Manager

    Catalent Pharma Solutions (St. Petersburg, FL)
    …Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems ; b) process improvement projects and Product Development ... Projects; c) all product process validation and cleaning validation documents; d) all...Preventive Maintenance and Calibration work order requirements for critical systems . This position is 100% on-site at the St.… more
    Catalent Pharma Solutions (09/03/25)
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  • Sr. Manager, Clinical Data Management

    Terumo Neuro (Aliso Viejo, CA)
    …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more
    Terumo Neuro (08/19/25)
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  • Automation Engineer III

    Catalent Pharma Solutions (Chelsea, MA)
    …(GMP) standards + Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating ... new and existing control equipment + Trains users on control system functionality (Programmable Logic Controller, Computer /Control Networks, Control Computers… more
    Catalent Pharma Solutions (09/27/25)
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  • Manager, QC Chemistry - Combo Products

    United Therapeutics (Research Triangle Park, NC)
    …testing activities for remediation activities, new project/product support (development, validation , etc.), implementation/maintenance of laboratory systems such ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
    United Therapeutics (09/24/25)
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