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Karl Storz SE & Co. KG
12d ago

Teamleiter Audit(m/w/x)

Tuttlingen
Full-timeWith Home OfficeManagement

Description

You will lead the European audit team, ensuring product safety and regulatory compliance. By managing audits and driving process improvements, you'll protect patient welfare and advance quality standards.

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Requirements

  • University degree, preferably technical field
  • Management experience and technical expertise
  • Knowledge of ISO 13485, MDR, QMSR
  • Experience with eQMS and MS Office
  • Customer- and service-oriented approach
  • Openness to creative solutions and feedback
  • Flexibility and adaptability
  • Independence, reliability, and implementation skills
  • Communication skills and regulatory handling
  • Business fluent English

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Lead the European audit management team
  • Manage team members technically and disciplinarily
  • Coordinate tasks and manage results transparently
  • Steer product safety and regulatory compliance strategies
  • Track strategies throughout the product life cycle
  • Decide on risk-based measures for deviations
  • Assess safety issues and regulatory non-compliance
  • Protect patient welfare and product safety
  • Fulfill international reporting and disclosure requirements
  • Communicate with authorities and notified bodies
  • Plan and conduct internal quality audits
  • Monitor ISO 13485 and MDR management systems
  • Lead and support external audits
  • Develop improvement and compliance measures
  • Drive change processes with specialist departments
  • Motivate and develop the team professionally

Tools & Technologies

eQMS toolMastercontrolMS Office

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Hybrid work
  • Flexible working hours
  • Mobile working

More Vacation Days

  • 30 vacation days

Additional Allowances

  • Various special payments

Learning & Development

  • Open in-house seminar program
  • Extensive e-learning offering
  • Professional development courses

Company Bike

  • Bicycle leasing

Retirement Plans

  • Private pension plan subsidy

Healthcare & Fitness

  • Company health management
  • Health activities
  • Sports activities

Childcare

  • Various childcare options

Team Events

  • Cultural activities
  • Leisure activities
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