Medical Device Auditor - USA/Remote
Role Overview: We are seeking an experienced Medical Device Auditor with experience in auditing IT systems to support our client engagements in Canada. The ideal candidate will have strong knowledge of QSR, GxP, ISO 13485, ISO 27001, and regulatory frameworks for medical devices and information systems. Key Responsibilities:
- Plan, conduct and lead audits of Medical Devices vendor/supplier.
- Ensure compliance with applicable standards and regulations (FDA, Health Canada, ISO, GAMP 5, etc.).
- Prepare detailed audit reports and recommend corrective/preventive actions.
- Work with cross-functional teams to ensure audit readiness and compliance maintenance.
- Support continuous improvement initiatives within QSR and IT infrastructure.
Required Skills & Experience:
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or equivalent.
- 5+ years of experience in auditing medical devices especially IT systems.
- Certified Auditor in ISO 13485 / ISO 9001 / ISO 27001 preferred.
- Strong understanding of QSR, GxP, CSV (Computer System Validation), and 21 CFR Part 11.
- Excellent communication and reporting skills.
Why Join Us
- 100% remote work flexibility across Canada.
- Opportunity to work with leading MedTech and IT clients.
- Collaborative, growth-oriented culture with global exposure.