Katalyst CRO

Quality Engineer III

Austin, TX, US

5 months ago
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Summary

Roles & Responsibilities

  • CAPA and non-conformance experience required.
  • Investigation experience required.
  • Managing system.
  • 6-7 years' experience.
  • Bach degree required.
  • Preferred exp in Med Device but not required.
  • Performs Quality and technical review of Nonconformance investigations (Company) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete.
  • Maintain an accurate log of Non-Conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of Company/CAPAs.
  • Provides hands-on guidance and training to all personnel performing activities within the Quality system.
  • Ensure documentation is complete before closure.
  • Assist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs.
  • Prepare monthly and quarterly metrics to present at Quality Review meetings.

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