Quality Engineer

1 month ago

Manchester, United Kingdom Real Staffing Full time

Our client are a fast growing medical technology start-up with a revolutionary non-invasive medical device product looking to revolutionise their respective therapy area.

They are looking for a Quality Engineer to be based in their Manchester HQ, reporting to the Quality Manager focused on supplier management and development of the QMS system. The position will also involve Quality Control activities e.g. product inspection and release.

Responsibilities:

  • Supplier Management (SCARS, KPl's, Supplier Assessments, Supplier Agreements, supplier re-qualification, supplier monitoring)
  • External audits of suppliers
  • Non-conformances (NCR and CAPA)
  • Customer Complaints
  • Product inspections
  • The Quality Engineer will review, inspect and authorise labels
  • Review & approve Device History Records (DHR) and other production documentation
  • Execute Product Release
  • Revise existing QMS documentation (SOP's, WI's policies)
  • Contribute to the development of new QMS procedures
  • Contribute to QMS Management Reviews
  • Track and trend QMS KPl's
  • Maintain applicable standards

Experience:

  • Operating to IS013485 and compliant processes & procedures
  • ISO13485 Lead auditor qualified or open to training
  • QA and preferably QC experience in a medical device company
  • Degree qualified or quality qualifications/experience

Desirable:

  • Familiarity with 21 CFR Part 820
  • Supplier evaluation and monitoring
  • Product inspection and release
  • Management of customer complaints and Non-conformance
  • Lead Auditor qualification

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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