Description
Real Staffing is seeking 3 Senior Design Assurance Quality Engineers for a top Medical Device client in the San Diego Area.Role:
As a Senior Design Assurance Quality Engineer you will be in a cross-functional role responsible for supporting the design and development of the company's medical device. You will facilitate the design controls in product development and sustaining changes, while supporting customer complaints and safety issue.
Position Requirements:
- BS in Engineering
- A minimum of 5 years experience in Medical Device Industry
- A minimum of 3 years experience in New Product Development or Design Control
- Working knowledge of FDA Quality System Regulations with auditing experience
- Working knowledge of ISO-14385 and ISO-14971 standards
- Process Validation (PMFEA, IQ,OQ,PQ), DOE, and SPC
- Good Verbal and Written Skills
- Knowledge of Statistical Software Tools
Established Experience With:
- New Product Development
- Design Control
- CAPA
- Root Cause Failure Analysis
- FMEA, FTA, HACCP
- Lean Six Sigma
Please reply if you feel you meet the above requirements and are interested in pursuing this opportunity, Cheers!
To find out more about Real please visit www.realstaffing.com