Auditor/Technical Expert for Medical Devices (m/f/d) with focus on EO sterilization and non-active medical devices

As a Notified Body for medical devices and in-vitro diagnostic devices as well as an accredited registrar for the certification of quality management systems, we are a strong partner and important service provider for the healthcare sector since 1994. With our locations in Stuttgart, Berlin, Tuttlingen, Vienna and Haifa, we are a competent international partner and always have a need for qualified specialist staff.

Be part of our team in our new branch office in Haifa and apply as an
Auditor and/or Technical Expert for Medical Devices (m/f/d) - with focus on EO sterilization processes and non-active medical devices

Das sind Ihre Aufgaben

Review quality management documentation and conduct audits at our customers’ sites and, where applicable

at their suppliers in accordance with applicable regulations and the quality management standard EN ISO 13485
Assess technical documentation, or parts thereof, for compliance with the applicable regulatory requirements
Prepare reports on the assessment and audit activities performed

Das bringen Sie mit

A successfully completed university degree in a scientific, technical or medical field, or another comparable qualification corresponding to at least Level 6 of the European

Qualifications Framework, equivalent to a bachelor’s degree
At least four years of professional experience in the development, manufacture, testing, conformity assessment or application of medical devices or related fields, including

experience in quality management and/or regulatory affairs
Knowledge and professional experience for at least 2 years, in the following product and/or process areas:
Ethylene Oxide (EO) sterilization processes (including validation and routine control according to EN ISO 11135);
Non-active medical devices sterilized by EO (e.g. single-use devices, surgical instruments or implants);
Microbiological testing and environmental monitoring in cleanroom manufacturing environments; and
Packaging systems for sterile medical devices (including shelf-life and sterile barrier validation according to EN ISO 11607)
Confidence in working with normative and regulatory requirements, combined with a high level of technical understanding
Willingness to travel nationally and internationally
Proficiency in written and spoken English, together with strong communication skills and the ability to assert yourself

Das bieten wir Ihnen

Work at our attractive location in Halonot HaCity or in a home office. We offer you there a full- or part-time job in a permanent employment as well as an attractive salary. You can expect an exciting job in an internationally active and constantly growing medium-sized company, comprehensive training and a team that is gladly looking forward to you.

Haben wir Ihr Interesse geweckt?

Wir freuen uns auf Ihre Bewerbung!