Auditor/Technical Expert – EO Sterilization & Non‑Active Medical Devices

About the role

Join a leading Notified Body as an Auditor/Technical Expert focused on ethylene oxide (EO) sterilization processes and non‑active medical devices. You will work from our Haifa branch or remotely, supporting customers across the healthcare sector.

Key responsibilities

• Review quality‑management documentation and conduct audits at customer and supplier sites in line with EN ISO 13485.
• Assess technical documentation for compliance with regulatory requirements.
• Prepare detailed reports on audit findings and assessment activities.
• Validate EO sterilization processes according to EN ISO 11135 and support routine control.
• Evaluate packaging systems and sterile barrier performance per EN ISO 11607.

Required profile

• University degree in a scientific, technical or medical field (or equivalent Level 6 qualification).
• Minimum four years of experience in medical‑device development, manufacturing, testing, conformity assessment or regulatory affairs.
• At least two years of hands‑on experience with EO sterilization, microbiological testing, clean‑room environmental monitoring, and sterile packaging validation.
• Willingness to travel nationally and internationally.
• Fluent written and spoken English with strong communication skills.

Required skills

• Ethylene Oxide (EO) sterilization validation
• EN ISO 11135 compliance
• EN ISO 11607 compliance
• EN ISO 13485 quality‑management systems
• Microbiological testing
• Environmental monitoring in cleanrooms
• Packaging systems for sterile medical devices

What we offer

• Permanent full‑time or part‑time employment
• Competitive salary
• Opportunity to work in an internationally active, growing medium‑sized company
• Comprehensive training and a supportive team environment