Sr Engineer (Quality)
Orange County Metro Area, CA
Life Sciences Industry
The quality engineer will work with an experienced engineering team and have have responsibilities in the following areas:
- Test method development
- Test method validation
- Design / Process Specification development
- Risk Management specifically Risk Management Worksheet (MDR Compliance)
- Design Verification
- Equipment validation for design verification testing
- Medical device background in Quality (highly preferred)
- Significant statistical knowledge pertaining to inspection method assessment.
- Knowledge of inspection equipment.
- Simple and electro-mechanical.
- CMM / vision systems preferred.
- Exposure to Tensil testing (highly preferred)
- Catheter design verification and/or manufacturing experience preferred. (Balloon catheter type would be ideal)
- Bachelor's Degree in Engineering
- Minimum 3 years experience. 5 years preferred.
- Quality and Six Sigma certifications preferred.