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Lalande-de-Pomerol

    Quality Assurance Engineer - Miami, United States - Primary Talent Partners

    Primary Talent Partners
    Primary Talent Partners Miami, United States

    3 weeks ago

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    Description

    Primary Talent Partners has an exciting opportunity with our client in the Miami, FL area. This is a contract position with a duration of 7 months and possibility for extension or conversion. No C2C candidates will be considered at this time.

    Pay Range: $41/hr - $46/hr
    Schedule: 8am - 5pm, M - F

    Responsibilities:

    • Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.
    • Ensure proactive compliance to all applicable internal, domestic, and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.
    • Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.
    • Lead extended Quality teams for design change projects.
    • Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, and System Risk Assessment documentation.
    • May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
    • Assures that products subjected to design changes are successfully transferred into the supply chain including manufacturing and service environments.
    • Participates in Design Reviews and develop, approve, and review associated documentation.
    • Responsible for Design History File (DHF) completeness and maintenance.
    • Utilize problem solving techniques ad take a broad perspective to identify innovative solutions.
    • Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise.
    Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

    If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at

    #PTPJobs

    #LI-PTP
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