Lead Auditor (Fully Remote)

Responsibilities

• Conduct remote audits of medical device quality management systems.
• Review objective evidence and provide structured audit reports.
• Ensure audit activities follow established methodologies and regulatory principles.

Qualifications

• Bachelor’s degree in a relevant scientific or engineering discipline.
• Minimum 4 years professional experience in the medical device industry.
• Minimum 2 years auditing QMS according to ISO 13485 and EU MDR.
• Flexible contractor model with remote work.
• Opportunity to evaluate innovative medical technologies.
• Autonomy in managing audit assignments.