Medical Devices Expert & Auditor / Quality Engineer
The Medical team is geared towards approving high-value medical devices intended for the international market and certification of quality systems.
Within this team we are looking for a Medical Devices Expert & Auditor.
As a Medical Device Expert & Auditor you have a wide range of tasks:
you are responsible for the assessment of technical files and the auditing of the quality system of your customers. You manage an extensive customer portfolio that reaches from high innovative start-ups to large multinationals, both national and international. Naturally, this portfolio is tailored to fit your field of expertise. You act as a linchpin and maintain frequent contact with your customers, colleagues, external experts like physicians, contractors, and authorities . You manage various projects simultaneously. In addition to managing your customer portfolio, you will have the opportunity to represent the company at conferences.
The position entails travelling within and outside Europe, approximately 20-30% of the time. Furthermore, you will either work from the company's office or from home after you are qualified.
In short: a highly challenging position that guarantees a combination of professional challenge, dynamics and variation!
- Higher vocational or university level education, preferably in life and/or engineering sciences;
- A minimum of 5 years experience in the field of medical devices, preferably in a product development/R&D position;
- Experienced in at least one of the following devices categories and areas of expertise: soft tissue implants, cardiovascular devices, drug device combinations, animal tissue and IVD;
- Experience with quality management systems (e.g. ISO9001 /GMP /ISO13485/ ISO14971);
- Knowledge of relevant laws and regulations (preferably CE/FDA/PAL);
- Experience with project management;
- Auditing experience is considered an advantage;
- Good command of the English language, both spoken and written.
We offer a challenging and varied job in a dynamic and international environment, working as part of an expert organization. The position is rewarded appropriately and offers good fringe benefits, dependent on age, experience and qualifications.
One of the primary notified bodies is looking to extend their team with medical device experts.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
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Uiteraard staat deze vacature open voor zowel mannen als vrouwen.