As a quality manager you are responsible for the development optimization and systematic application of quality management systems (EN ISOCFR Part 820) as well as for maintaining all regulatory requirements including ISO 14971 for risk management.
You are responsible for maintaining and introducing new processes into the quality management system in collaboration with all departments
You are jointly responsible for the CAPA system for processing internal and external complaints as well as their compliance and monitoring.
You work on planning internal and external audits carry them out and ensure precise followup
You design concepts and procedures for process and quality improvement and with your coordination enable the implementation of optimal and structured change management
The creation initiation processing and monitoring of corrective measures as well as the organization of the quality area according to market and customer requirements round off your area of responsibility