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Passion for quality and safety

Medical Devices Expert & Auditor – Arnhem

How your day looks like

The business line Medical is a leading and fast growing Notified Body for the Medical Device Industry. Therefore we are constantly looking for medical auditors or technical file reviewers. Dealing with cutting-edge medical innovations, we provide our clients with worldwide market access through executing conformity assessments for high risk devices. We work together with a team of ± 35 experts from our office in Arnhem (the Netherlands), with the ultimate goal to ensure patient safety for medical devices.

Responsibilities

After an extensive internal training program in Arnhem, you:

  • Execute audits and processes independently;
  • Are responsible for the assessment of technical files and the auditing of quality systems of your costumers (from high innovative start-ups to large multinationals, both national and international);
  • Act as a linking pin (account manager) and maintain frequent contact with your costumers, colleagues, external experts like physicians, contractors and authorities;
  • Will have the opportunity to represent DEKRA at conferences;
  • Will travel within and outside Europe, approximately 20-30% of the time.

What we expect from you

  • A (Bachelor or) University level degree in life- and/or engineering sciences is a must;
  • A minimum of 4 years of fulltime work experience in medical device related industry, including at least 2 years in R&D (or QA/RA);
  • Experienced in at least one of the following devices categories and areas of expertise: Active medical devices, Active implantable medical devices, Soft tissue implant, Cardiovascular devices, Drug device combinations or Animal tissue;
  • Experienced with quality management systems and relevant laws and regulations, at least CE;
  • Project management and auditing experience is considered an advantage;
  • English language skills are a must;
  • You are eligible to work and preferably also already live in the Netherlands.

Our offerings

Our employees are the face and the driving force behind DEKRA. As employer we devote a great deal of attention to personal development. We offer a competitive salary and an excellent benefits package such as 25 days of holiday, an additional 13 ADV days, a success bonus and a discount on several insurances. Working from home is possible.

About DEKRA

DEKRA Certification is the expert in testing, inspection, auditing and certification. We are part of the international assessment organization DEKRA, a company with a real passion for safeguarding quality and safety in the areas of technology, mobility and environment. With over 45.000 employees in more than sixty countries we are one of the largest players in the industry.

DEKRA likes to look for new colleagues itself, acquisition in response to this vacancy is therefore not desirable.

Questions?

If you have any further questions regarding Job-ID please contact:
Helma de Winter +31889683862

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