Quality Engineer

CK Group are recruiting for a Human Factors Quality Engineer to join a company in the pharmaceutical industry on a contract basis for 12 months.

Salary: Up to £25.98 per hour PAYE or up to £29.12 per hour via umbrella company.

Human Factors 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
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external
• Support the assessment of external design companies and suppliers
• Support the generation of all regulatory submission data and content for assigned device projects

• Hold a relevant scientific degree or have equivalent working experience
• Working knowledge 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
• Understand Good Manufacturing Practices (GMP).

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 50% and 50% home working.

Apply:

For more information, or to apply for this Human Factors Quality Engineer please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 161 254.

It is essential that applicants hold entitlement to work in the UK

Please note:

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

INDKA