Quality Engineer required
Location: North West
Contract 12 months
My client are a within the medical device industry based in theNorth West and are looking for a Quality Systems Engineer.
- You will be expected to perform quality systems work in all aspects of quality, in regards to the process and products relating to disposable, sterile, and non sterile products manufactured within a sterile clean room environment
- Your key role will be to ensure product issues are immediately investigated and adequate corrective/preventive action implemented
- Shall ensure al quality systems procedures are established under one system that implements the requirements of the FDA QSR, ISO9001, ISO 13485, Medical Device Directive and other national and international regulatory requirements as may be established from time to time
- Supporting process complaint handling, supplier management and internal and external quality audits, CAPA component compliance and QMS training
- Ensure the CAPA system, internal quality audits and supplier management systems are operating effectively
- Handles non-conformances /deviations and tracks status of corrective action to ensure closure
- Provide assistance and training to personnel who conduct investigations and handle exceptions
- Coordinates RAQA presentations ensuring that meeting materials are available
- Encourages data driven performance and achievement of quality objectives
- Conducting risk reviews for issues to ensure corrective decisions are taken regarding product or compliance issues.
- Develops systematic approach based upon the principles of risk management
- Shares input to operational and compliance projects to drive improvement within the business
- Provides technical support to the QC team and liases with R and D to resolve specifications issues.
Desired Skills and Experience:
- Experience in GMP and ISO quality system standards in particular ISO9001, ISO13485
Proven record of experience in a medical device industry or a regular related or similar environment
To find out more about Huxley Associates please visit www.huxley.com