4h ago
Medical Device Quality Engineer
UK - Remote
$60k-$80k / year
full-timemid Remotehealthcare
💼 About This Role
You'll join Scarlet's Quality Team to audit and certify quality management systems for innovative medical AI companies. You'll ensure compliance with ISO 13485, EU MDR, and other standards while designing efficient audit processes. This role offers the chance to work with bleeding-edge medical AI and a rapidly growing company.
🎯 What You'll Do
- Audit and certify QMS of healthcare companies
- Interpret and implement quality requirements (ISO 13485, EU MDR, etc.)
- Design efficient audit processes for customer data
- Maintain and expand Scarlet's regulatory approvals
📋 Requirements
- Bachelor's degree in engineering, CS, physics, or equivalent
- Minimum 4 years professional experience in medical devices
- Minimum 2 years in quality management (ISO 13485, EU MDR, ISO 14971)
- Experience auditing medical device QMS against ISO 13485, EU MDR, ISO 14971
✨ Nice to Have
- Experience with ISO 27001
- Ability to read and analyze normative texts
- Adaptability to work autonomously on ambiguous tasks
🎁 Benefits & Perks
- 💰 Competitive salary (£60K – £80K)
- 📈 Equity offered
- 🏠 Remote work within the UK
- 🌍 Opportunity to work with cutting-edge medical AI companies
📨 Hiring Process
Recruiter screen, hiring manager call, regulatory skills interview, cross-functional problem-solving interview, founder interviews, references, then offer.
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