Quality Engineer

3 weeks ago

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


Salary:

Hourly -Up to 21.62 PAYE or 24.23 Umbrella

Quality EngineerRole:
  • Lead designcontrol and risk management activities for combination productdevelopment programs.
  • Support and facilitationof effective risk management activities at external designcompanies and manufacturing facilities related to assignedprojects.
  • Ensure combination productdevelopment activities are compliant with quality and regulatorystandards.
  • Provide input and support to designvalidation including, but not limited to, human factors engineeringassessments.

YourBackground:
  • BSc inappropriate science & engineering discipline with previousexperience in pharmaceutical combination product and/or deviceindustries.
  • History of working in accordancewith the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR4, and the EU Medical DevicesRegulation.
  • Experience in design controls andrisk management for combinationproducts.
  • Familiar with Human FactorsEngineering - Usability Engineering.
  • Familiarwith device assembling manufacturingprocesses.

Company:

Ourclient is one of the world's premier innovative biopharmaceuticalcompanies, discovering, developing and providing over 160 differentmedicines, vaccines and consumer healthcare products to helpimprove the lives of millions of people in the UK and around theworld every year.

Location:

Thisrole is based at our clients site in Cambridge but offers hybridworking 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 allcorrespondence.

Pleasenote:

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

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