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| Job Location | Gateshead |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
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.The Company:Our client are a market leader in their field and have pioneered advances in technology and instrumentation.Location: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.Your Background: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