Every day our products and services help to save lives around the globe. Therefore, we make quality and reliability our number one priority. Lead the European audit management team: Take on the technical and disciplinary management of the auditor and audit management team and ensure clear task coordination and transparent results management. Steer product safety and regulatory compliance strategies: Plan, track and develop company-wide strategies for product safety and regulatory compliance throughout the entire product life cycle. Decide on risk-based measures in the event of deviations: Assess safety-related issues and non-compliance with regulatory requirements and make appropriate decisions to protect patient welfare and product safety. Ensure regulatory reporting and disclosure requirements are met: Ensure timely fulfilment of international reporting requirements, particularly to authorities, notified bodies and customers. Plan and conduct internal audits within the framework of the European quality management system: Create and implement the internal audit programme for the European quality management system and monitor relevant management systems (such as ISO 13485, MDR, QMSR, MDSAP, NMPA, etc.). Conduct external audits: Lead and support external audits in the European quality management system and ensure appropriate communication with authorities, certification bodies and, if necessary, customers and internal departments. Manage change and improvement processes: Develop improvement and compliance measures with the team and drive their implementation together with the specialist department. Develop your team professionally and personally: Motivate and develop your team through targeted measures to take audit management to a new level, so that the team is perceived as a valuable point of contact within the organisation. With the capable audit management team, you will work together to advance the KARL STORZ organisation as a whole. Completed university degree, preferably in a technical field Several years of management experience in a comparable position and technical expertise at manager level Demonstrable comprehensive knowledge of the applicable regulations ISO 13485, MDR, QMSR, etc., as well as the ability to ensure their pragmatic implementation Knowledge of the use and interpretation of digitalisation tools (eQMS tool, e.g. Mastercontrol), and experience in using MS Office Customer- and service-oriented approach to work Openness to and enjoyment of creative solutions, as well as a personality that supports the further development of your environment with constructive feedback Flexibility and ability to adapt to different personalities and situations High degree of independence, reliability and structured thinking, as well as strong implementation skills Strong communication skills, ability to integrate and confident handling of complex regulatory issues Business fluent English Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required 30 vacation days and various special payments Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more Corporate benefits and bicycle leasing Subsidy for private pension plan and company health management Various childcare options – at the headquarters in Tuttlingen Health, sports, cultural and leisure activities – offers vary depending on location HR Contact #J-18808-Ljbffr