Quality Assurance Specialist - Cambridge, Cambridge
Client: Newton Colmore Consulting Ltd
Location: Cambridge, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 44675ad159b5
Job Views: 4
Posted: 24.04.2025
Expiry Date: 08.06.2025
Job Description:
We are seeking a Quality Assurance Specialist in Cambridge for a growing Medical Devices company. The role involves assisting in the development of the Quality Management System (QMS) in compliance with ISO 13485 standards. Candidates from alternative sectors with ISO 13485 training are encouraged to apply.
Your responsibilities will include creating and managing technical files for various Medical Devices, including Class I, Class IIa, and Class IIb devices. You will work closely with Medical Devices experts, primarily focusing on Quality Assurance, with support from the parent company's QA Manager.
This position is suitable for candidates with a few years of experience in ISO 9001 or QMS, as well as more experienced professionals seeking to lead QMS development or transition into the Medical Devices sector under ISO 13485 standards. Due to active QMS setup, daily presence in the office is required initially, with potential for hybrid working over time.
The ideal candidate will have a degree related to Quality Assurance, Quality Engineering, or Design Assurance. A good understanding of Regulatory Affairs is advantageous. Experience working alongside manufacturing teams in Medical Devices QA, especially from a Quality Engineering background, is desirable but not essential.
Interested candidates are encouraged to apply promptly to avoid missing out. For more information, contact Andrew Welsh, Director of Medical Devices Recruitment at Newton Colmore Consulting, at +44 121 268 2240, or submit an application to be contacted by our team.
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