Quality Systems Specialist
5 days ago
We are looking for a Quality Systems Specialist to join our team at Quantumdx Group. The successful candidate will be responsible for ensuring products and design and development of future products are compliant with the requirements of ISO 13485 and ISO 14971 and IEC 62304.
Main Responsibilities:
- Champion the highest level of quality & process and undertake training;
- Work with purchasing staff to establish Quality requirements from external suppliers;
- Help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files;
- QA review of both internal and contractor generated documentation;
- Take an active role in the risk management process;
- Support the administration of a company-wide risk-based comprehensive training system;
- Design and deliver training sessions to ensure understanding and compliance of all employees.
Requirements:
The ideal candidate will have industry experience working within a Quality Management System, with some specific experience of working with IVD medical devices. They should also possess outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
Salary: £60,000 - £75,000 per annum
Location: UK
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