What are the responsibilities and job description for the Quality Engineer III_US position at Mindlance?
M-F normal business hours
on-site role 5x a week
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
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.
- 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.
These roles are required to support compliance activities at the Plainsboro facility while site personnel are focused on FDA responses.
EEO :
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans."