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Quality Engineer (Senior)

Blackfield Associates are currently supporting a prestigious client in Cambridgeshire in the search of a Quality Engineer to support either the Assay Development group of Software business unit on a permanent basis.

You will be responsible for providing insight and guidance of quality and regulatory compliance whilst ensuring supporting the maintenance and improvement of the QMS (Quality Management Systems).You will also provide support on third party audits, software development life cycle, development , validation planning and quality systems (CAPA's, Test Protocols, Design Documentation, etc...)

In order to be consider for this opportunity you will need experience in Quality Engineering ideally within a Medical Device (ISO13485) or Invitro Diagnostics (IVD) environment.

Ideally you have experience in 21CFR 820, 21CFR Part 11, ISO 13485, IEC62304, ISO14971, GAMP5 and understanding of design/development of products (NPD/NPI).

If you are interested in the opportunity, please send your CV to or call Craig on +442392 322346

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