Vacancy Sr Qa Officer – Eerbeek


Organization

4 AUG ’22: For an organisation focused on specialty eye care, we are currently looking for a Senior Quality Officer for their manufacturing site in Eerbeek. They design and manufacture innovative, high-performance contact lenses to meet a remarkably wide range of wearers’ needs.

Function

In this role as Sr QA Officer, you will define, create, act conform and improve the Quality Policy, the internal SOP’s and the requirements conform the ISO 13485, the MDR and the relevant regulatory affairs. You will be responsible for the negotiation of changes/verification of implementations of all companywide processes. You will coordinate, plan and monitor the process of different tests, calibration & validation. Furthermore, you will:

  • Assess all quality elements and ensure complaint handling;
  • Perform and communicate the internal, process- and product audits, external audits, follow-up of CAPA’s and autoclave training;
  • Perform process control, the release of incoming inspection & final product;
  • Write, verify and improve the SOPs resulting on operational and tactical level in English resulting as input to (& output) the management review;
  • Lead improvement and validation projects ad hoc and based on trend analysis, as the output of the management review
  • Participate in defining, creating, maintaining and improving the Quality policy;

Requirements

For this role, we require a professional with a minimum of 5 years of relevant work experience and excellent knowledge of the English language. We are looking for someone who can work independently when they need to, while also being a good teamplayer. Furthermore, having experience with the following would be a plus:

  • Excellent knowledge of GMP- and Iso 13485 / MDR standards, risk management and change process;
  • Technical writing experience;
  • Good communication skills;
  • Solution-oriented;

Offer

Working for this organisation means that you can contribute to the health of the world’s population with your knowledge. In addition, you work in an environment in which safety, quality and productivity are among the people. In addition, the organisation can offer you the following:

  • 30 vacation days;
  • Pension plan;
  • Company bonus;

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Tessa Heemskerk
Senior Associate | Medical Devices

+31 6 12 43 13 59
t.heemskerk@qtcrecruitment.com