Demo

Quality Engineer

Katalyst Healthcares and Life Sciences
Plainsboro, NJ Full Time
POSTED ON 2/21/2025
AVAILABLE BEFORE 5/19/2025

Responsibilities :

  • Monitors, inspects, and evaluates products to ensure predetermined quality standards are met. Develops and updates testing-related documentation, including test cases, plans, and flaw-reporting procedures.
  • 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.

Requirements :

  • CAPA and non-conformance experience required.
  • Investigation experience required.
  • Managing system.
  • 6-7 years experience.
  • Preferred exp in Med Device but not required.
  • Bachelor's Degree is required.
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