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    Quality - Investigator - Quality Assurance (Mid Level) - Westborough, United States - Genesis Corp./New Journey AI LLC

    Genesis Corp./New Journey AI LLC
    Genesis Corp./New Journey AI LLC Westborough, United States

    4 weeks ago

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    Description


    Genesis10 is currently seeking a Quality - Investigator - Quality working a contract through November 1, 2024 with our client in the healthcare industry in their Westborough, MA location.


    Responsibilities:
    Execute the triage, investigation, and closure of product quality complaints.


    Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.

    Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.


    Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.

    Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers


    Qualifications:
    Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or Master's level program

    Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required

    Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)

    Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance

    Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints

    If you have the described qualifications and are interested in this exciting opportunity, apply today

    Ranked a Top Staffing Firm in the U.S.

    by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every yearin contract, contract-for-hire, and permanent placement roles.

    With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.


    Benefits of Working with Genesis10:
    Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.


    The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.

    Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)

    Medical, Dental, Vision

    Health Savings Account

    Voluntary Hospital Indemnity (Critical Illness & Accident)

    Voluntary Term Life Insurance

    401K

    Sick Pay (for applicable states/municipalities)

    Commuter Benefits (Dallas, NYC, SF)

    Remote opportunities available


    For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others.

    To learn more and to view all our available career opportunities, please visit us at our website.

    Genesis10 is an Equal Opportunity Employer.

    Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    Genesis
    #J-18808-Ljbffr


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