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ZEISS medical technology
2d ago

Quality Management System (QMS) Manager(m/w/x)

Jena
Full-timeOn-siteSenior

Description

You will drive the evolution of the company's Quality Management System while ensuring regulatory compliance and CSV excellence during the transition to SAP S/4Hana.

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Requirements

  • •Master's degree in natural sciences, engineering, business administration, or comparable qualification
  • •Extensive professional experience in Quality Management within regulated industries
  • •Knowledge of ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements
  • •Proven experience with Computerised System Validation (CSV)
  • •Familiarity with FMEA, CAPA, 5-Why, and risk management
  • •Experience with SAP and BPMN 2.0 (advantageous)
  • •Structured and analytical approach to complex information
  • •Independent, solution-oriented work style with strong communication
  • •Fluency in English and German skills (advantageous)

Education

Master's degree

Tasks

  • •Develop and maintain the Quality Management System
  • •Improve the QMS per ISO 13485 and MDR standards
  • •Implement MED QMS requirements within SAP-supported processes
  • •Collaborate with partner teams on process implementation
  • •Plan and document risk management activities
  • •Develop and monitor validation strategies for computerized systems
  • •Advise cross-functional teams on quality and regulatory topics
  • •Coordinate CSV activities with internal and external partners

Tools & Technologies

ISO 13485MDR21 CFR Part 11Computerised System Validation (CSV)FMEACAPA5-WhySAPBPMN 2.0

Languages

English – Business Fluent

German – Basic

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