IVDR Assessor

A company is looking for an IVDR Experienced Assessor.

Key Responsibilities

Conduct audits of manufacturers' quality management systems and suppliers / subcontractors

Perform surveillance audits and maintain effective customer relationships

Manage auditing teams and complete projects related to IVDR procedures and documentation

Required Qualifications

Technical college degree in a relevant product or medical area

Minimum 4 years of work experience in the In-Vitro diagnostic medical device industry

At least 2 years of experience in design, manufacturing, testing, or as an assessor / auditor

PhD in a relevant area can substitute for 3 years of work experience

Preferred knowledge of medical device management systems and compliance standards