Mate Istel

Managing IQ / OQ / PQ validation activities, process qualifications and qualification protocols Designing, optimizing and standardizing quality processes and cross-functional documentation frameworks Negotiating and managing legal quality agreements and compliance-related customer contracts Oversight of hygiene, sanitation, and GMP-compliant environmental monitoring within manufacturing Strategic supplier qualification, development and risk-based supplier monitoring

Technical and disciplinary management of the quality management system according to ISO 13485 Preparation of the company for transitioning products to MDR. Complaint and deviation management Leading supplier audits Supplier management Initiating and maintaining continuous improvement processes (CIP) In this role, I also lead quality circles and working groups that deal intensively with QM issues and monitor the processing of complaints in order to ensure maximum customer satisfaction.

Development, establishment, and implementation of ISO 13485, including two external certifications by a notified body. Digitalization and streamlining of processes Complaint and deviation management Continuous improvement processes Conducting internal audits Leading supplier audits Developing processes Optimization of quality documents Hygiene management in the manufacturing area Supplier management Scale management Developing a data protection strategy