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Quality Engineer 1

  • Location

    Elkhart, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    22828

  • Published:

    8 months ago

  • Expiry date:

    2021-01-20

The Quality Engineer will assist in the maintenance and support of the Quality Management System activities at an in-vitro diagnostic manufacturing site.

This position is an individual contributor role and will interact with multiple functions within the site.

  • Manage calibration and maintenance system.
  • Coordinate internal and 3rd party calibration activities.
  • Document, review, and file quality records.
  • Manage the electronic calibration and maintenance system including enrollment, change, and asset tracking.
  • Assist Quality Group in support of related processes and documentation.
  • Strong value orientation with the ability to lead teams and positively influence outcomes.
  • Ability to effectively communicate with internal and external customers.
  • Ability to demonstrate lean leadership skills.

Required Knowledge/Skills, Education, Experience

  • BS in Life Science - Biochemistry, Biology, or Chemistry disciplines preferred.
  • Requires technical knowledge in IMTE calibration and related electronic management systems.
  • Require technical knowledge in the applicability of 21 CFR 820 regulations and ISO 13485:2016 standard requirements.

Preferred Knowledge/Skills, Education, Experience

  • IMTE Calibration Management Experience.
  • Regulated Industry Experience.