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Quality Engineer

Cambridge
3 weeks ago
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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 projectsYour Background:

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).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 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 (phone number removed) or email (url removed). Please quote reference (Apply online only).

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

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