Design Quality Engineer - Katalyst Healthcares & Life Sciences

Demonstrated knowledge in application and implementation of IVDR 2017/746 and ISO 13485.

Experience with DHF creation and maintenance and design control processes.

Assist in development and maintenance of records and procedures within the quality management system for regulatory compliance.

Participate in regulatory audits and certification inspection, helping to ensure operational compliance with established procedure.

Evaluate and interpret regulatory requirements and industry standards applicable to our operations.

Conduct comprehensive compliance assessment to identify gaps and areas of improvement.