CAPA and Compliance Quality Engineer
2 weeks ago
Summary
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. Bachelor's Degree is required. 7+ years of experience.
Key Responsibilities:
· Performs Quality and technical review of Nonconformance investigations (NCs) 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 NCs/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.
Preferred Skills:
· 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
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