Description
The Role:As a Quality Engineer you will support the creation and implementation of a QMS. It is essential that you play a cross-functional role in support of complete life-cycle for new products from concept to commericializtion, with on-going engineering and production support. You will also be involved with risk analysis in support of overall risk management, while supporting supplier quality functions.
The Client:
The client is a well funding medical device company developing a class III implantable device. They currently in the process of becoming ISO Certified and are poised to attain CE Mark approval.
Responsibilities:
- New Product Development
- Desigin Verification and Validation
- Perform Risk Assessmens (FMEA, FTA, Risk Analysis)
- Internal and External Audits
- Develop and Implement Quality Systems Documentation
Requirements:
- B.S: Engineering or similar technical field
- 3-5 yers experience in the Medical Device industry
- Exceptional understanding of ISO-13485 and ISO-14971
- Experience with Class III products highly preferred
- CQA highly preferred
Salary:
85,,000
To find out more about Real please visit www.realstaffing.com