Are you in %country%? Do you want to visit our website in another language?

¿Está en España? ¿Desea ver nuestra página web en otro idioma?

Вы находитесь в %country%? Открыть наш сайт на другом языке?

Êtes-vous en France ? Aimeriez-vous visiter notre site Web dans une autre langue ?

日本にいますか 私たちのウェブサイトを別の言語で訪問したいですか?

Befinden Sie sich in %country%? Möchten Sie unsere Website in einer anderen Sprache anzeigen?

Você esta no %country%? Deseja visitar nosso site em outro idioma?

您在中国吗? 您是否想访问我们其他语言版本的网站?

Quality & Process Consultant – Design Controls (HW)

Quality Management Associate Munich, BY, Germany

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:

Job Description

The Design Controls team within the Quality Management department at Brainlab is looking for a Quality & Process Consultant - Design Controls with a focus on hardware development processes. Our team implements and continuously improves the Brainlab product development processes and corresponding tools. You will be responsible to shape our processes to enable efficient and compliant development of active and non-active medical device hardware. 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 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

Qualifications

  • University degree in Production Engineering, Mechanical Engineering, Medical Technology or equivalent
  • At least 3 years of experience in design engineering or production engineering in a regulated industry (medical devices preferred)
  • Experience in insourcing of manufacturing from a development perspective, including lean manufacturing
  • Knowledge in Advanced Product Quality Planning (APQP) and Poka Yoke is a plus
  • Knowledge of medical device hardware related standards and regulations such as IEC 60601, FDA 21 CFR Part 820 and ISO 13485 desired
  • 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, a structured nature as well as persistence

 

Additional Information

  • 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 
  • 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.  

Apply now

Your HR Contact Person
Géraldine Endres
Senior Recruiter

Géraldine Endres [email protected]

Share job