Quality Assurance Specialist

Quality Assurance Specialist

Medical Devices / ISO13485 Quality Management Systems - Essential

Location: Heywood

Salary: £40K+

The Role

Our client is seeking a Quality Assurance Specialist to support and continually improve their Quality Management System within a regulated Medical Device manufacturing environment.

Role focuses on:

* Continued regulatory compliance to ISO13485, whilst assisting with Technical Documentation under (EU)2017/745, (EU)2017/746 to maintain device compliance.

* Maintain and improve the company's Electronic Documentation Management System (EDMS) by Progressing, reviewing and update quality procedures, risk assessments and work instructions.

* Key contact for quality/compliance whilst hosting external regulatory and accreditation bodies.

* Coordinate and manage the internal/process audit programme to drive improvement assisted alongside external consultancy.

* Manage document...

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