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Teamleiter Audit

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KARL STORZ

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Location:
Germany , Tuttlingen

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Responsibility:

  • 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

Requirements:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
January 24, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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