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Quality Engineer 1

  • Location

    Tarrytown, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    23352

  • Published:

    8 months ago

  • Expiry date:

    2021-03-13

Job description:

  • Evaluate safety complaint escalations, make decisions on MDR reporting, and documenting those decisions.
  • File MDRs when needed and communicate (as appropriate) to the Authorized Representative or Regional Unit.
  • Work with members of other teams to review, assess, and close potentially adverse events (pMDRs), including MDR reporting related to IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems.
  • Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
  • In addition, support the Commercial Product Quality (CPQ) department when working on post market IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems related issues from the Escalation Review Council (ERC).
  • Provide CPQ support for the above-mentioned systems Product Health Teams.
  • Display of a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected.
  • Demonstrate a significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues.

Requirements:

  • 2-3 years of experience with complaint handling and Medical Device Reporting (US and Outside of the US).
  • Good writing, communication and organizational skills necessary.
  • Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.

Key Working Relationships: Primarily intra organizational contacts and external contacts.