CK Group are recruiting for a QA Manager to join a leading medical diagnostics company at their site based in Gateshead on a permanent full-time basis.
Our client are a market leader in their field and have pioneered advances in technology and instrumentation.
This role is located in Gateshead and the site is easily commutable from the A1(M) and surrounding towns/cities in the North East.
QA Manager Role:
Your main duties will be to:
- Oversee the release of manufactured product from the sites
- Act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use
- Act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
- Assist with the maintenance of the site Quality Management System
- Work with the regulatory, quality control and production teams to ensure product requirements are met prior to release to the market.
- Work closely with the Quality Control Manager and Regulatory Affairs Manager to ensure product is released to the market only if quality and regulatory requirements are met.
- Maintain high levels of integrity and regulatory compliance.
The ideal candidate for this role will have:
- At least 2 years experience and background in medical device or pharmaceutical quality assurance at a management level.
- Knowledge and experience of Quality Management Systems e.g. ISO9001, ISO 13485 and the US Quality System Regulation.
- Sound working knowledge of Good Manufacturing Practices, including personnel training skills.
- Design and preparation of Standard Operating Procedures.
- Review and approval of compliance of company production and QC documentation.
- Non-conformance investigation skills.
Entitlement to work in the UK is essential. Please quote reference 54164
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 54164
Website: CK Group
- Posted: 28th July 2022
- Expires: 25th August 2022