Auditing and Compliance Officer

18 hours ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Quantumdx Group Full time
About the Opportunity

We are seeking an Auditing and Compliance Officer to join our team at Quantumdx Group. The successful candidate will be responsible for maintaining and improving our Quality Management System, identifying potential improvements and efficiencies, and helping to develop, revise and implement quality procedures and policies.

Main Responsibilities:

  • Manage individual projects and work packages as required;
  • Maintain and administrate the electronic Quality Management System Q-Pulse;
  • Promote the benefits of a quality system to all employees;
  • Gather relevant data on QMS performance to facilitate statistical reporting;
  • Asset management and control including overseeing calibration and maintenance of assets as necessary;
  • Help to compile and maintain Medical Device Files, Technical Files and Device Master Records;
  • QA review of both internal and contractor generated documentation relating to development, verification, validation as well as device manufacture and production records;
  • 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: £50,000 - £65,000 per annum

Location: UK


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