The Design Controls team within the Quality Management department at Brainlab is looking for a Quality & Process Consultant - Design Controls. Our team implements and continuously improves the Brainlab product development processes and corresponding tools.
Within your role you will be responsible to shape the R&D processes to enable efficient and compliant medical device development. You will manage process improvement, interact with the different R&D departments to collect feedback and provide support and guidance. Also you will support external quality audits of Brainlab by authorities, such as FDA and Notified Bodies within your area of expertise. With your open nature, good communication and excellent analytical skills you are a perfect fit for our team.
Your duties include:
- Maintenance and improvement of the processes for the development of medical devices
- Management of process improvement projects
- Implementation and follow up-of action items and process CAPAs
- Contact person for R&D on development process topics
- Support external audits of Brainlab