💼 About This Role

You'll lead remote audits of medical device manufacturers' QMS under ISO 13485, EU MDR, and UK MDR as part of Scarlet's notified body activities. Your work will directly enable cutting-edge medical AI to reach patients safely and quickly.

🎯 What You'll Do

• Conduct remote audits of QMS under ISO 13485, EU MDR, UK MDR
• Provide clear audit documentation and evidence-based conclusions
• Deliver consistent, high-quality audits aligned with Scarlet's methodology
• Collaborate with clients on audit planning and follow-up

📋 Requirements

• Bachelor's degree in software engineering, computer science, or related field
• Minimum 4 years experience in medical device industry
• Minimum 2 years auditing QMS under ISO 13485
• Experience as Lead Auditor with notified bodies or accreditation bodies

✨ Nice to Have

• Experience with software medical devices (SaMD)
• Working knowledge of ISO 14971, IEC 62304, IEC 82304
• Knowledge of cybersecurity standards

🎁 Benefits & Perks

• 🏖️ Flexible scheduling based on audit demand and availability
• 🌍 Fully remote work from anywhere in Europe
• 📋 Consultant auditor role with autonomy

📨 Hiring Process

Introductory call with Emily (45 min), auditor competence interview (45 min), case study with Johan (max 60 min + 30 min presentation), references, then offer & onboarding.