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Doral

    Development Quality Engineer - Doral, United States - The Fountain Group

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    Description
    Job Description

    Job Description


    Job Duties:


    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.
    Assure that products subjected to design changes are successfully transferred into the supply chain including manufacturing and service environments.
    Participate 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.


    Qualifications:
    Bachelor's degree, preferably in Engineering, and 2+ years of experience.
    Experience in medical devices and knowledgeable in 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.
    Experienced with DHFs, Design controls, Design Verification, Design Validation, Risk management.
    Company Description The Fountain Group is a nationwide staffing firm with over 80 Fortune clients.

    Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.

    Our success is a team effort.

    Browse our website below for additional information on our company.

    The Fountain Group

    4505 Woodland Corporate Blvd, Tampa, FL 33614
    "We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people."

    Company Description

    The Fountain Group is a nationwide staffing firm with over 80 Fortune clients.

    Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards.

    Our success is a team effort.\r\rBrowse our website below for additional information on our company.\r\rThe Fountain Group\r\r4505 Woodland Corporate Blvd, Tampa, FL 33614\r"We work in Life Sciences, Clinical, Engineering, IT, and more.

    Above all, we specialize in people."
    #J-18808-Ljbffr

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