Job Description
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. This is a hybrid role with 50% onsite in Cambridge.
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 effective risk management activities at external design companies and manufacturing facilities
* Ensure combination product development activities are compliant with all required standards
* Support the generation of all regulatory submission data
Your 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 compa...