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    Sr. Design Quality Engineer - Albany, United States - Regeneron Pharmaceuticals, Inc

    Regeneron Pharmaceuticals, Inc
    Regeneron Pharmaceuticals, Inc Albany, United States

    3 weeks ago

    Default job background
    Full time
    Description

    We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.

    In this role, a typical day might include the following:

  • Reviewing design and development paperwork and records for compliance to internal procedures and regulations
  • Ensuring accurate justification of statistical analysis and hypothesis testing
  • Reviewing technical reports as well as documents for Design History Files
  • Participating in device risk management activities including UFMEA, DFMEA, PFMEA
  • Aiding in establishing statistical controls in development and transfer to manufacturing processes
  • Verifying data integrity, electronic data storage and data sheet validations
  • Reviewing and coordinating with QA Validation for all test method and design validations
  • Reviewing activities related to Design Verification and Design Transfer of Medical Devices
  • Ensuring work product meets regulations
  • Supporting scientific, complaint, and test failure investigations
  • Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis

    • This role might be for you if:

  • You have knowledge of the combination device development process
  • You have experience with device risk management activities
  • You have a quality mind-set

    • To be considered for this role you must hold a Bachelor's degree in an Engineering subject area and the following amount of work experience in combination device or medical device industry for each level:

  • Quality Engineer: 2+ years
  • Sr. Quality Engineer: 5+ years

    • Level is determined based on qualifications relevant to the role.

    #REGNQA

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