Vacature - Jouw nieuwe functie

QA/RA Manager

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Deel deze vacature

17 JAN ’24: We are currently seeking a QA/RA Manager for a revolutionary cancer diagnostics organisation. They aim to develop state-of-the-art technology to detect cancer as early as possible, improving people's lives and solving one of society's biggest burdens. If you are prepared to make a significant impact as the QA/RA Manager, please reach out to me as soon as possible.

Details

Medical Devices

Quality/RA

40 uur per week

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Zo maak jij het verschil

In this position, you will be responsible for the QMS processes and ensuring the correct implementation of ISO 13485 and harmonised standards. You will be reporting to the Head of Operations and Clinical Affairs, and knowing laws and regulations applicable to IVDs, such as the EU IVDR and FDA regulations, is definitely a plus. Thoroughly checking the conformity of devices in alignment with the Quality Management System before release is a critical aspect of your role. You will play a central role in guaranteeing the accuracy and currency of technical documentation and the EU declaration of conformity.

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Wat jij mee brengt

As a professional, you bring along the willingness to learn and develop yourself proactively with an ownership mentality, and:
  • At least two years, preferably more experience in quality management systems and ideally also Regulatory Affairs (more senior profiles are also welcome to apply);
  • At the minimum, a Bachelor’s degree in biomedical sciences or another relevant scientific discipline;
  • At least two years, and preferably more than four years of professional experience in quality management systems, ideally within IVD;
  • A minimum of two, and preferably more than four years of experience in IVD Design Control processes;
  • Affinity with molecular genetics techniques, including PCR and DNA extraction methods;
  • Experience with the promotion of compliance with procedures in the QMS.
 
 

QTC logo icon Wat wij bieden

Jouw voordelen

You will have the opportunity to make a significant contribution to the development of high-quality products that can save lives. Join the organisation and be a part of a team that values innovation, collaboration, and excellence.

Furthermore, you can expect:

  • Competitive salary according to your experience;
  • 8% vacation allowance;
  • Excellent pension scheme;
  • Flexible working hours within a hybrid working environment.
You will work regularly from the office in Leiden. Please note that they do not offer Visa Sponsorship for candidates outside of the EU.

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