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    Quality Compliance - New York, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC New York, United States

    3 weeks ago

    Intellectt Inc background
    Technology / Internet
    Description

    Role:
    Assoc Spec, Quality Compliance

    Location:
    Irvine, CA

    Duration:

    12 Months


    Job Description:

    Summary:
    The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate

    Key Responsibilities:
    Manage customer relationships and expectations during the course of complaint investigation and resolution process
    Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
    Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
    Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
    Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
    Prepare and submit final customer correspondence
    Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint
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