Senior Quality Assurance Specialist
1 month ago
CK Group is seeking a Senior Quality Assurance Specialist to join their team in Cambridge. This is a contract position for 12 months.
Key Responsibilities:
- Lead design control and risk management activities for combination product development programs.
- Support and facilitate 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.
Requirements:
- BSc in an appropriate science and 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.
About the Company:
Our client is a world-leading biopharmaceutical company, discovering, developing, and providing over 160 different medicines, vaccines, and consumer healthcare products to improve the lives of millions of people in the UK and around the world.
Location:
This role is based at our client's site in Cambridge, with hybrid working arrangements offering 2-3 days per week on-site.
Apply:
Applicants must hold entitlement to work in the UK. Please quote job reference 106705 in all correspondence.
Notes:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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