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Quality Engineer

2 months ago

Cambridge, United Kingdom CK Group Full time
CK Group are recruiting for a Quality Engineer, to join a company in the Pharmaceutical industry at their site based in Cambridge, on a contract basis for 12 months.


Salary:

Hourly - Up to 21.62 PAYE or 24.23 Umbrella

Quality Engineer Role:
  • Lead design control and risk management activities for combination product development programs.
  • Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Ensure combination product development activities are compliant with quality and regulatory standards.
  • Provide input and support to design validation including, but not limited to, human factors engineering assessments.

Your Background:
  • BSc in appropriate science & engineering discipline with previous experience in pharmaceutical combination product and/or device industries.
  • History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
  • Experience in design controls and risk management for combination products.
  • Familiar with Human Factors Engineering - Usability Engineering.
  • Familiar with device assembling manufacturing processes.

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:

This role is based at our clients site in Cambridge but offers hybrid working with 2/3 days a week on site.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 106705 in all correspondence.

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.