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QA Manager

Tyne and Wear   •  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


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 54164
  • Posted: 28th July 2022
  • Expires: 25th August 2022

CK Group

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