Quality Engineer III
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Plainsboro, NJ 08536
Description:
Responsibilities:
- Performs Quality and technical review of Nonconformance investigations (Company) and CAPAs within defined timeframes.
- Ensure investigations and root cause analyses 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 the Quality Systems team as needed to investigate non-conformances and ensure proper implementation of CAPAs.
- Prepare monthly and quarterly metrics to present at Quality Review meetings.
- These roles are required to support compliance activities at the Plainsboro facility while site personnel are focused on FDA responses.
- and non-conformance experience required.
- Investigation experience required.
- CAPA Managing system.
- Bachelor's Degree is required.
- 7+ years of experience.
- Bach degree required.
- Preferred exp in Med Device but not required.
- 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.