Quality Systems Engineer
Hourly Rate TBA
My client is looking for a Quality Systems Engineer to work within the Medical Device Industry based in theNorth West.
The client is looking for someone who will undertake activates including:
- Structuring RAQA presentations to ensure meeting materials are available in a timely manner
- Plans and conducts work requiring judgment in the independent evaluation, selection and the adaptation of standard quality system techniques, procedures and criteria; devises new approaches to problems as encountered
- Key role is to ensure any product related issues are dealt with promptly, investigated and the right corrective/preventive action is implemented.
- Ensuring that the Quality System procedures are established under one system that will adhere to the requirements of FDA QSR, ISO9001, ISO13485, Medical Device Directive.
- International regulatory requirements may be established from time to time
- Provides input to projects to drive improvements within the business
- Creating systematic approaches using the principles of risk management
- Ensuring the CAPA, internal quality audit, and the supplier management system are operating successfully
- Provide assistance and training to personnel who conduct investigations and handle exceptions
- Providing support to Quality Control
- Supplier Management and undertaking internal and external audits
- CAPA, component compliance and QMS training
It is desirable that the candidate has experience in GMP and ISO quality systems standards (ISO 9001, ISO 13485 assessor is desirable
To apply for this role please forward you're CV and I will be in touch over the coming week.
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