Work Flexibility: Hybrid

Your mission

• 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.

Your talents

• 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

Your Benefits

• 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​

Carsten Engel | Recruiter Talent Acquisition

carsten.engel@karlstorz.com