CAPA and Compliance Quality Engineer

2 weeks ago


plainsboro, United States Intellectt Inc Full time

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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