Medical Devices Quality Assurance Specialist

4 weeks ago


Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

Job Description: We are seeking a Quality Assurance Specialist to assist in the development of our QMS system for ISO 13485 standards.

This role involves creating and managing technical files for several Medical Devices lines, including Class I, Class IIa and Class IIb Medical Devices.

You will collaborate with Medical Devices experts and be responsible for Quality Assurance duties. Assistance from the parent company's Quality Assurance Manager will be available.

This is an excellent opportunity for someone with a Quality Assurance background to lead the development of a QMS system, particularly in the Medical Devices sector under ISO 13485 standards.

Apart from Quality Assurance experience, having a good understanding of Regulatory Affairs is highly advantageous. Working alongside manufacturing teams for these medical devices is also a key aspect of this role.



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