IVDR Assessor

Job Summary

A company is looking for an IVDR Experienced Assessor.

Key Responsibilities

• Conduct audits of manufacturers' quality management systems and suppliers, producing corresponding records and reports
• Perform surveillance audits and follow-up activities to maintain high service delivery standards and customer relationships
• Manage auditing teams and ensure compliance with IVDR standards while completing projects related to IVDR procedures and documentation

Required Qualifications

• Technical college degree in a relevant medical or product 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, or testing
• Practical experience in assessing performance evaluation data for in-vitro diagnostic medical devices
• PhD in a relevant area can substitute for 3 years of work experience, provided it includes 2 years in design, manufacture, or testing
• Knowledge of medical device management systems, compliance standards, and auditing techniques is preferred