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Technical Quality Manager

We are seeking a Technical Quality Manager to support the development of a new generation of portable, hand-held diagnostic medical devices.

The role will involve taking ownership of the quality management as a whole and ensuring compliance with ISO13485, Medical Devices Regulations and any other relevant standards.


The role will also involve setting up and maintaining the quality system, supporting the technical development of the devices and taking the devices through CE marking and medical device certification.


This will include:



  • Definition and review of company quality procedures.

  • Ensure compliance with company quality procedures.

  • Generation and review of both project and technical documentation.

  • Compilation and submission of design files.

  • Liaising with notified bodies and relevant authorities.

  • Management of contractors and suppliers.

  • Supporting and performing verification and validation of devices.


This is a hands-on role that offers a unique opportunity to be an integral part of a new and innovative company at a very early stage.

This will allow any candidate to be involved many aspects across the business and therefore significantly broaden their experience and allow them to grow with the company.


Essential Skills and Experience



  • 2 - 5 years of quality management experience, preferably in a medical related field.

  • Broad knowledge of engineering principles.

  • Risk management processes, preferably in accordance with ISO 14971.

  • Quality management, preferably in accordance with ISO 13485.


Desirable Skills and Experience



  • Ember of the Chartered Quality Institute

  • Any CQI qualifications

  • Knowledge of laser safety standards and practices

  • Knowledge of software development practices

  • Management of clinical trials

  • Planning and project management

  • Knowledge of statistics, design and execution of experiments.


  • Start: ASAP
  • Rate: Pension, Shares Option Scheme
  • Location:
  • Type: Permanent
  • Industry: Other
  • Recruiter: re&m
  • Tel: 01442 773145
  • Fax: 0845 5195 139
  • Email: to view click here
  • Posted: 2019-10-23 15:35:26 -

  • View all Jobs from re&m