Auditor/Technical Expert for Medical Devices (m/f/d) - with focus on EO sterilization processes 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 branch office in Haifa and apply as an 

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

These are your tasks

• 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

Your skills

• 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

This is what we offer you

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.

Have we piqued your interest?

We look forward to receiving your application!