About the position
#

Your key role is to support design quality activities and product integrity by coordinating labelling, translations, and UDI management. As a Junior Design Quality Specialist, you contribute to essential quality and regulatory processes, including Quality Management, Risk Management, Post-Market Surveillance, and CAPA. You support the creation, maintenance, and accuracy of compliant product documentation and ensure it remains up to date throughout the entire product lifecycle, in close collaboration with cross-functional teams. Do you want to help us to make lung function testing accessible to everyone everywhere, and to improve the lives of millions of people with lung diseases? Then you have come to the right place!

Why us?
#

We offer an attractive location, fair pay, good social benefits, flexible working hours, hybrid work, and the best conditions in which to do excellent work. This includes comprehensive onboarding, professional and modern technology, and a collegial and supportive working environment. We promote equal opportunities, diversity, and inclusion.
If this profile describes you and you would like to work at a fast-growing company in a global environment, then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you, the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.

Tasks
#

Labelling & Translations

• 
  
• Drive labelling activities for assigned products in line with regulatory and market requirements.
  
• Coordinate translations of labels, operator manuals, and software-related texts.
  
• Ensure accuracy, consistency, version control, and timely implementation of updates.
  
• Perform verification activities to confirm compliance with defined requirements.
  

UDI Management

• 
  
• Manage UDI activities for assigned products, including assignment, maintenance, and database updates.
  
• Ensure alignment between UDI, labelling, and technical documentation.
  
• Support UDI-related changes across the product lifecycle.
  

Quality & Compliance Support

• 
  
• Support PMS and risk management activities, ensuring alignment with labelling and IFU content.
  
• Contribute to CAPA activities related to labelling, UDI, and product information.
  
• Maintain quality records and support audits as required.
  

Your profile
#

• 
  
• Bachelor’s degree in biomedical engineering, life science discipline or comparable technical or scientific field.
  
• 0-2 years of professional experience in quality management, design quality, regulatory affairs, or another regulated environment.
  
• Exposure to documentation, labelling, translations, or product development activities within the medical device industry is an advantage
  
• Experience supporting coordination with internal teams and external service providers, including basic task tracking and follow-up actions.
  
• Good communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
  
• Solid writing skills, with high attention to detail and accuracy when preparing and maintaining documentation.
  
• Good knowledge of relevant standards such as ISO 14971, IEC 62366, IEC 60601‑1.
  
• Very good user knowledge of documentation tools (e.g. MS Office, Polarion).
  
• Professional fluency in English and German; additional languages are a plus.
  

Contact
#

We kindly ask for direct applications only. Unsolicited dossiers from agencies will not be considered, and we decline all responsibility for any fees related to such submissions.

E-Mail schreiben