The Quality Management department at Brainlab is looking for a Process Manager Hardware Development in the Design Controls team. The Design Controls team oversees the Brainlab R&D process landscape including processes for Hardware Development and Design Engineering. You will be responsible to shape our processes to enable efficient and compliant hardware development. With your open nature, good communication and excellent analytical skills you are a perfect fit for our team. You will be supporting external quality audits of Brainlab by authorities, such as FDA and Notified Bodies, as well as the implementation and follow up of action items and CAPAs in your area of expertise. You are an expert for Hardware Development within a regulated industry? We are happy to receive your application.
Your duties include:
- maintenance and improvement of the processes for the development of medical device hardware and other R&D related processes
- implementation and follow up of action items and CAPAs
- management of specific improvement projects
- contact person for R&D and Production for hardware development process topics
- support external audits of Brainlab