Your matter

You want to develop yourself or your company?

 

I’m happy to support you in reaching your goals in the areas organization, process and personnel: pragmatically, user friendly and with high quality.


Topics

Potential examples for cooperation

  • Ceation and maintenance of quality management systems (ISO 13485:2016, FDA 21CRF820)
  • Develop and implement a new strategy or policy
  • Organizational changes and following adoption of business processes, e.g. due to
    • Growth
    • Acquisitions
    • Restructuring
    • Introduction of digital processes
    • External changes of regulations or markets
  • Potential to improve business or manufacturing processes, teams and personnel

 

Approach

How to realize your goals together?

  • Quality management design and process architecture: linkage of different processes and interfaces of departments
  • Create or update customized business processes and optimization regarding efficiency, effectiveness, compliance and scalability (Lean, Kaizen, NC/CAPA, digitalization)
  • Project and program management of change projects
  • Creation, update or reviews of technical and quality documentation
  • Consultancy of executive management, leadership, process owners and teams
  • Training of quality management topics as NC/CAPA, audit, document management etc.
  • Training of soft skills to manage projects, change and processes

 


My Background


  •  > 15 years experience as consultant and department head in product development and quality management
  • Leading teams, processes, projects, initiatives (e.g. establish QMS in start-ups, restructuring, Lean for quality management systems, new quality policy, integration of acquisitions)
  • Coaching and development of leaders and teams
  • Technical knowledge regarding production and development of products
  • International regulations concerning medical devices (ISO 13485:2016, FDA 21CFR820 etc.)
  • Different work areas: University, start-ups, small and medium size companies, corporation with focus medical industry and mechanical engineering
  • Multilingual work in interdisciplinary, international and virtual teams
  • Mechanical Engineering (TU Darmstadt), PhD in Medical Engineering (RWTH Aachen)
  • Training as systemic business coach (Artop, Berlin, Humboldt Universität, Berlin)

Contact

Dr.-Ing. Ute Wiesemann

Reiterstraße 22

D-79100 Freiburg

+49 176 45779464

ute(at)wiesemann.org

Key Cooperations

Biomech Innovations AG,

Switzerland

ODI Medical AS, Norway