Description
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. In our newly collaboration with DEKRA, we have the opportunity to develop your career as a medical devices expert and auditor.
In the thriving medical devices industry, the quality and safety of the products becomes more and more important. 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.
- 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 customers (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 customers, 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.
- 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;