Quality Engineer

  • Salary: Competitive
  • REF Number: 00049611
  • Consultant: George Truman
  • Contact: 01246 457730
  • Date Published: 14.01.2021
  • Sector: Medical Devices
  • Location: Stirling, South/Central Belt Scotland
  • Discipline:

CK Technical are recruiting for a Quality Engineer to join medical technology company at their site based in Stirling on a 12 month fixed term contract.

The Company: Our client is a medical technology company developing and manufacturing diagnostic-led care solutions.

Location: This role is located in Stirling.

Quality Engineer Role:

Your main duties will be:

  • Creation and management of the IVD Directive 98/79/EC CE marking Technical files.
  • Update IVDD 98/79/EC TechnicalFiles to comply with IVDR 2017/746
  • Manage change control impacting CE marking Technical Files
  • Assisting with internal audits, NCs and CAPAs.

Your Background:

The ideal candidate for this role will have

  • A broad and in-depth knowledge of ISO13485, FDA 21CFR Part 820 and IVDR.
  • Experience in the creation and management of CE technical files.
  • Experience working in the medical device or life science industries.
  • Knowledge of pre or post launch IVD or medical activities would bebeneficial.

For more information or to apply for this Quality Engineer position, please contact George Truman on 01246 457730 or email gtruman@ckgroup.co.uk, quoting job ref 49611

It is essential that applicants hold entitlement to work in theUK

TECHGEN

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