IVDR Assessor

Job Summary

A company is looking for an IVDR Experienced Assessor.

Key Responsibilities

• Conduct audits of the manufacturer's quality management system and suppliers, preparing corresponding records and reports
• Perform surveillance audits and maintain high service delivery standards to ensure effective customer relationships
• Manage auditing teams and complete projects related to IVDR procedures, ensuring compliance with standards

Required Qualifications

• Technical college degree in a relevant product or medical area (e.g., Biology, Chemistry, Medical Technology)
• Minimum of 4 years of work experience in the In-Vitro diagnostic medical device industry, with at least 2 years in design, manufacturing, testing, or as an assessor/auditor
• Practical experience in assessing performance evaluation data for in-vitro diagnostic medical devices
• A PhD in a relevant area can substitute for 3 years of work experience, provided it includes 2 years in design, manufacture, or testing
• Preferred knowledge of medical device management systems, standards, and compliance/auditing techniques