Senior Medical Device Auditor

A company is looking for a Senior Auditor Medical Device 13485 - Independent Contractor (Remote U.S.).

Key Responsibilities

Conduct audits of medical device quality management systems to ensure compliance with ISO 13485 standards

Prepare audit reports and provide feedback to clients regarding their quality systems

Collaborate with clients to develop corrective action plans based on audit findings

Required Qualifications, Training, and Education

Experience in auditing medical device quality management systems

Certification in ISO 13485 or related quality standards

Background in regulatory compliance for medical devices

Relevant degree in a scientific or engineering discipline

Proven experience in a similar role or industry