Description
Quality Engineer Medical Devices - £300-£350 per dayAn exciting new opportunity has become available for a Quality Engineer in a new device company. Candidate's responsibilities will be to support assigned projects through validation to completion. Candidates will also be required to have strong documentation skills and experience within a highly regulated sector.
Quality Engineers main responsibilities:
- Support operations providing directed support compliant with ISO 13485 and FDA 21 CFR Part 820
- Risk Analysis: pFMEA and dFMEARegional anesthesia needles and trays
- Review and approval of quality related documentation via ORACLE PLM.Closed-system drug transfer devices
- Assist in the development process optimisation, measurement system analysis and formal process validation techniques
- Compilation and reporting Quality Measurement Indices as required.
- CAPA team member.
- Comply with requirements of GDP and GMP.
Required experience:
- Minimum 5 years medical device engineering experience
- Batch or continuous flow manufacturing
- Precision mechanical small scale components
- Producing high standard documentation within regulated industry.
- Audit consultant experience in ISO13485, MDD93/42/EEC & ISO9001
- Experience with the following devices
- Intravenous catheters
- Needles and syringes
- Safety-engineered and auto-disable devices
- Prefillable drug delivery systems
This role will pay above market rate for the right candidate.
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact Oliver Davies on
To find out more about Real please visit www.realstaffing.com