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

• 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

• 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

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.