You probably know someone close to you who has undergone open-heart surgery and is experiencing the enormous impact of this. With us you help to bring a solution to the market so that it is no longer necessary to fully open the chest in the future with bypass surgery. As a result, many more heart patients can be helped. How beautiful is that?

AMT Medical has a small, passionate team of 15 professionals (young and old). We are based in Ede with the corporate office and production facilities (including a cleanroom). In Utrecht (Science Park) we have laboratories for bench testing.

Function description:

• You support the Director Quality and Regulatory on all activities regarding the Quality Management System (QMS) and Regulatory Affairs.
• Support the supervision of the required QA/RA processes and maintain quality and regulatory awareness at all relevant AMT functions.
• Develop and maintain QMS compliance following ISO 13485:2016, 21CFR 820 (FDA), EU Medical Device Regulation and other applicable (product) standards and guidelines. Preferably also knowledge of other regulations (such as FDA).

Qualifications and educational requirements:

• Relevant bachelor’s or master’s degree preferred in technical or life science related topic.
• At least 3 years of experience in a QA/RA position in a medical device company.
• Knowledge of or experience with ISO 13485, ISO 9001, 21 CFR 820, EU Medical Device Regulation (MDR) and preferably FDA experience, as well as relevant (product) standards/regulations.
• Trained as QMS auditor.

Preferred Skills:

• Highly proficient in spoken and written English, proficiency in other languages is a plus.
• Ability to write quality and Technical File documentation at scientific level.
• Effective interpersonal communication skills – both written and oral.
• Accurate, detail oriented and able to see the big picture.
• Result driven, willing to take that extra step.
• Work independently and be self-motivated.

We offer:

• An international work environment in a diverse team.
• Salary according to education and experience.
• 25 paid holidays (based on full time) and a pension plan.

If you recognize yourself in above profile, send your application and CV to joke.heemskerk@amt-medical.nl.
In case of questions, please contact us by Email.

^{Acquisition because of this advertisement is not appreciated.}