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QA Specialist III - Medical Devices

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Des Plaines, United States of America
Salary undisclosed

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Role: QA Specialist III

Location: Des Plaines, Illinois - 60018-3315

Duration: 09 Months

Job Description

  • Prior experience working in Supplier Quality
  • Excellent technical writing skills
  • Prior experience initiating/writing, evaluating and completing Corrective and Preventive Actions (CAPA).
  • Work experience in an FDA-regulated environment
  • Familiarity with CFR 820, ISO 9001:2015, and ISO 13485:2016
  • Strong background in Data Analytics
  • Strong experience in PowerBI (Dashboard creation, data visualization)

Preferred Experience

  • Certified Lead (External) Auditor

Description

  • Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
  • BS degree and/or 5+ years equivalent experience