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Lalande-de-Pomerol

    Staff Development Quality Engineer IV - 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 a 12-month contract opening for a Staff Development Quality Engineer IV with one of our pharmaceutical clients in Miami, FL.


    Job Title:
    Staff Development Quality Engineer IV

    Pay:
    $ $58.00/hour

    Location: 100% Onsite in Miami, FL - local candidates only
    Term: 12-month contract (possibility of extension/conversion to FTE, depending on performance)

    Work Schedule:
    Mon - Fri, 8am - 5pm

    Note:
    No C2C or sponsorship is provided


    Job Description:
    The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective.

    The primary role of the position is to provide guidance and direction to cross-functional core teams to meet design control requirements in support of the market release of new products.

    The position also supports post-launch design changes for fielded products.


    RESPONSIBILITIES:

    Provide strategic direction for new product development and 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 with 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 a particular focus on design controls, risk management, and document controls.

    Led extended Quality teams for new product development and 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, Software Requirement documents, and associated Software Verification test procedures and reports, and System Risk Assessment documentation.

    May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
    Assures that newly developed products are successfully transferred into the supply chain including manufacturing and service environments.
    Participates in Design Reviews and develops, approves, and reviews associated documentation.
    Responsible for Design History File (DHF) completeness and maintenance.
    Utilize problem-solving techniques and take a broad perspective to identify innovative solutions.
    Interact frequently with other functional areas and operating entities that require specialized depth and/or breadth of expertise.


    QUALIFICATIONS:

    Bachelors degree in engineering or science discipline with seven years of experience in a regulated environment or masters degree in engineering or science discipline with five years of experience in a regulated environment.

    Experience in the application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design change.

    A high level of autonomy and critical thinking is required. Teamwork oriented.
    Must be able to multi-task and prioritize in a fast-paced environment.

    Must have strong verbal and written communication skills and be capable of producing detailed and comprehensive quality system documentation and reports.

    Computer skills (MS Office products).
    ASQ Certified Quality Engineer (CQE) is preferred.
    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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