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Quality Engineer

Houston Metro Area, TX

Post Date: 03/06/2018 Job ID: JN -032018-21085 Job Type: Scientific
Serving as Supplier Quality Engineer (SQE) representative to work with supplier on multi-department projects.

Tasks include:
-Reviewing supplier QMS documentation and ensure the document complies with regulatory, industry internal requirements (including SOP, work instruction and validation documents).
-Serving as SQE liaison and working with supplier on validation projects, process mapping projects and nonconformance resolutions and CAPAs.
-Travel to supplier site and represent Alcon to interact with supplier.

  • Working knowledge of FDA QSR and ISO 13485
  • Experience with process validation including IQ, OQ and PQ.
  • Experience with technical writing, including procedures, validation protocols and reports.
  • Fluent with MS Office Suite.
  • Able to travel to Mexico on monthly basis.
  • Bilingual (English and Spanish) is a plus (not required).
BS in engineering or science field.

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