Quality & Process Consultant – Risk Management
Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.
The Design Controls team within the Quality Management department at Brainlab is looking for a Quality & Process Consultant with a focus on the Risk Management process. 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, in particular within the area of risk management. You will manage process improvement and associated tool projects, 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
- Degree in engineering or life sciences preferred, but other degrees may be considered
- Professional experience within the area of Design Controls/development of medical devices, in particular in the application of risk management (ISO 14971)
- Knowledge of medical device related standards and regulations such as FDA 21 CFR Part 820 and ISO 13485
- Knowledge of the Polarion ALM tool
- Excellent analytical and abstract thinking skills
- Very good communication and documentation skills
- Very good English skills - written and verbal communication, including presentation skills
- Solution orientation and a structured nature
- A mutually-supportive, international team
- Meaningful work with a lasting impact on medical technology
- 30 vacation days, plus December 24th and December 31st
- Flexible working hours as well as hybrid work model within Germany
- Bike leasing via cooperation partner "BikeLeasing"
- Parking garage and safe underground bike storage
- Award-winning subsidized company restaurant and in-house cafes
- Variety-rich fitness program in our ultra-modern 360m2 company gym
- Regular after work, team, and company events
- Comprehensive training and continuing education opportunities
Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.
Your HR Contact Person