DEKRA
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 at our office 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 preferably already live in the Netherlands or otherwise are willing to relocate to the Netherlands.
Our offerings
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. Through our DEKRA Global Learning Management System, you have the option of following various online training courses, so that you can continue to develop.
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.
About DEKRA
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, Audit, 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.
Questions?
Do you have any questions about this vacancy? Please contact Teun Arends. You can reach him at +31 88 96 83134.
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