Quality Assurance Specialist
Medical Devices / ISO13485 Quality Management Systems - Essential
Location: Heywood
Salary: According to experience
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 control processes and qua...