DE
DE01 DEU Fresenius Medical Care D. GmbH
9 Tage

Head of Design Quality Assurance(m/w/x)

Vollzeit
mit Homeoffice
Senior
Keine Angabe
Bad Homburg vor der Höhe

As the Head of Design Quality Assurance, you will lead a global team to ensure design quality across various product types. This role involves defining strategies, promoting continuous improvement, and ensuring compliance with regulations while collaborating with cross-functional teams.

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Anforderungen

  • Bachelor’s or master’s degree in engineering or similar technical field
  • Minimum 5 years in research and development, regulatory affairs or quality management
  • Advanced knowledge of medical device regulations
  • Advanced knowledge of quality management and risk management standards
  • Knowledge of internal and external processes and corporate quality management requirements
  • Solid knowledge of CAPA methodology
  • Knowledge of Medical Device field and application
  • High engagement on achieving targets and objectives, proactive and solution-oriented approach, ability to work cross-functional
  • Good and professional relationship and communication with international colleagues and superiors
  • Fluency in English and German, both written and spoken
Bachelor-Abschluss
ODER
Master-Abschluss

Berufserfahrung

5 Jahre

Deine Aufgaben

  • Provide global leadership to the DQA team
  • Define and implement the DQA strategy and operating model
  • Drive team development and resource planning
  • Ensure effective task distribution and performance delivery
  • Promote a culture of continuous improvement and operational excellence
  • Represent the DQA function in leadership meetings and quality committees
  • Contribute to the Design Quality leadership team and global strategy
  • Lead the global design quality assurance strategy
  • Harmonize design quality processes across the organization
  • Coordinate design control activities for product development projects
  • Oversee compliance with applicable regulations and internal SOPs
  • Establish and maintain design quality processes and tools
  • Monitor global consistency and performance of design assurance execution
  • Align with manufacturing and supplier quality teams for product realization

Sprachen

Englischverhandlungssicher

Deutschverhandlungssicher

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