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QA Manager

QA Manager

South Holland, Medical Devices, fulltime

Are you looking for a modelling job in a world leading healthcare provider? Do you want to get the opportunity to make a difference in people's live? And at the same time the company will invest in your professional development? Here is the perfect function for you!

For one of my key-clients I'm urgently looking for a QA Manager. You will ensures the company compliance with MDR and you will work closely with the management, subsidiaries and other sales channels.

The function

In this great opportunity you will be responsible for:

    • Maintaining managing and improving the company's group ISO 13485/9001 certified quality management system.
    • Own and manage this QMS database.
    • Manage and take the responsibility for the certified body audits and internal audits. As in, evaluating, defining and monitoring the implementation of the necessary actions.
    • Manage the Quality Management System required activities (such as management review meetings, quality objectives, status overviews for management and other staff
    • Regularly collaborate with the company's global headquarters on QA and RA; and implement relevant processes.

Requirements:

  • Bachelor degree in a relevant field
  • 3+ years of work experience in the role of quality engineer or qa manager in the medical device or pharma industry
  • Strong knowledge of ISO 13485 and ISO 9001
  • Knowledge of ISO 14001, OHAS 18001 and ISO 27001
  • Strong knowledge of the EU Medical Device Directive and other regulations, standards (e.g. IEC 90901-1 series) and guidelines applicable on medical devices
  • Strong knowledge of and experience with risk management
  • Fluent in English written as well as verbal

Interested?

Could this be the next step in your career? Send your most up-to-date CV to Real Life Sciences or call +31 (0)20 522 1588 and ask for Anneloes Frese. If you would like to ask me additional questions, feel free to contact me! (+ 31 (0)20 522 1588 or a.frese"realstaffing.com).