The business line Medical is a leading and fast growing Notified Body for the Medical Device Industry. 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 international experts from our office in Arnhem (the Netherlands), with the ultimate goal to ensure patient safety for medical devices. Within this team 10 experts focus on Active Medical Devices. Typical examples of active medical devices are:
imaging devices, for example CT scanners, X-ray equipment, MRI scanners and ultrasound equipment;
monitoring and alarm devices, for example ECG, EEG, blood pressure, oxygen saturation and temperature;
medical device software for various applications;
therapeutic devices, for example lasers, phototherapy devices, pumps, ventilators, electrosurgical equipment and electrical stimulators. As the work for this active group is growing rapidly, we are looking for a new Active Medical Device Auditor (28-40 hours per week)
After an extensive internal training program at our Arnhem office, you:
execute audits independently;
are responsible for the assessment of technical files and the auditing of quality systems of your customers (from highly innovative start-ups to large multinationals, both national and international with different kind of active medical devices);
act as a linking pin and maintain frequent contact with your customers, colleagues, external experts, contractors and authorities;
will travel approximately 20-30% of your time. Most customers (±70%) are located in the Netherlands, and within Europe;
optionally, you will choose for a position as Technical File reviewer only and not auditing quality management systems. In this position, it is possible to work 24 – 40 hours a week and work merely from home.
What we expect from you
a Bachelor or University degree in life- and/or engineering sciences is a must; For example: electrical or electronic engineering, physics or biophysics, biomedical engineering or computer and software technology;
you have a minimum of 4 years of fulltime work experience in active medical device related industry, including at least 2 years in R&D or QA/RA;
experienced with quality management systems and relevant laws and regulations, at least CE;
project management- or auditing experience is considered an advantage;
English language skills are a must, Dutch language skills are nice to have;
you are eligible to work in the Netherlands and preferably already live in the Netherlands or willing to relocate to the Netherlands.
Our employees are the representatives of as well as the driving force behind DEKRA. That is why we offer an attractive salary and benefits including 25 vacation days and 13 ADV days on an annual basis, a success-sharing scheme and a discount on various insurance policies. When you grow, DEKRA grows with you. That is why we offer an extensive online training package from GoodHabitz.
Above all, what we find most important is enabling Ambition, Autonomy and Variety. Working at DEKRA means working in a challenging position, within a team of independent experts and in a dynamic and international environment.
DEKRA has been active in the field of safety for more than 100 years. Today we are one of the world’s leading expert organizations with 45,000 employees worldwide, sales totaling 3.4 billion euros and activities in more than 50 countries.
In the Netherlands, with over 1,000 employees, we are active in various fields, including Product Testing & Certification, Audits, Industrial Inspection, Safety Consulting, Rail and Claims & Expertise.
Among our core activities are the testing and certification of consumer, industrial, automotive and ICT products, products used in hazardous areas and medical devices for markets worldwide. DEKRA enables manufacturers to access almost all markets by testing and certifying their products according to required, internationally accepted standards, such as CE marking, ENEC, Cenelec, IEC and KEMA-KEUR.
In addition to a focus on the safety of electrical and electronic products, we also offer services aimed at electronic vehicles, communication and wireless technology and electromagnetic compatibility (EMC) aimed at high tech developments around the 'Internet of Things'.
The vision for the company’s 100th birthday in 2025 is that DEKRA will be the global partner for a safe world. And you are welcome to join!
DEKRA likes to look for new colleagues itself, acquisition in response to this vacancy is therefore not desirable.
If you have questions regarding this vacancy, please contact:
Teun Arends +31889683134