Design Quality Assurance Engineer

Join Sonova’s global quality team and play a key role in ensuring our innovative medical devices meet the highest standards of safety, performance, and compliance. As a Design Quality Assurance Engineer, you’ll partner with R&D teams to guide product development from concept to launch, ensuring regulatory excellence every step of the way.

 

 

Key Responsibilities

 

• Support design control activities for new development projects (Hardware/Software)
• Perform risk management activities for assigned projects
• Support with design FMEA activities
• Actively collaborate with cross-functional development teams 
• Support design changes and post-launch improvements
• Contribute in continuous improvement projects

 

 

Your Profile

 

• Proven practical experience in a regulated industry, preferably medical devices
• Bachelor’s or master’s degree in engineering, science, quality is a plus
• Knowledge of ISO 13485 and ISO 14971
• Hands-on experience with design control, product risk management and design FMEA
• Hands-on experience with software development, IEC 62304/1, IEC60601 series is a plus
• Proficient in MS Office; experience with tools like Visio, Project, or Polarion is a plus
• Fluent in English