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 1300 dedicated and inspiring individuals in 19 offices worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values of inspiration, simplicity and integrity:

Manager Quality System

What to expect

As Manager Quality System you are an expert in ISO 13485 implementation at our medical device company. Together with your team you will interact with Brainlab departments and partners internationally to manage compliance of our procedures with external requirements and to maintain our QM certifications. You will be organized in a team of other QM managers who take care of e.g. Regulatory Affairs and the CAPA system. Your responsibilities will be:

  • maintain and improve the Brainlab Quality System
  • drive the improvement of the global Quality System
  • support Brainlab internal divisions in the implementation of required procedures
  • manage the internal audit program
  • organize external audits including MDSAP audits and FDA inspections
  • maintain and perform document control
  • be responsible for education of employees in quality matters e.g. QM/GMP training
  • manage the QMS team

What you offer

  • Knowledge and professional experience (5y) in medical device Quality System management according to FDA 21 CFR 820 and ISO 13485
  • Degree in engineering or life sciences preferred, other degrees may be considered
  • Analytical, organized and decisive personality
  • Strong interpersonal and leadership skills
  • Persuasive power
  • Excellent written and verbal communication skills including presentation skills, also in English
  • Good MS Office knowledge

Ready to apply?

We offer you a professional business environment, an international team and a performance-oriented environment as a base to consequently realize your ideas. Through distinguished training, efficient education and the regular exchange of experience with colleagues from different departments, you will be demanded and promoted, both professionally and personally.

Interested? Then we are looking forward to receiving your online application including your start date and salary expectation!

Contact person: GĂ©raldine Endres