Design Quality Assurance Engineer (Senior)
Sonova AG
Key information
- Publication date:26 June 2025
- Workload:100%
- Contract type:Unlimited employment
- Place of work:Staefa
Job summary
Join Sonova in Staefa as a Senior Design Quality Assurance Engineer! Be part of a global quality team ensuring top-notch medical devices.
Tasks
- Ensure R&D processes comply with internal and external regulations.
- Support design validation and user needs definition activities.
- Collaborate with teams to identify and prevent quality issues early.
Skills
- 5+ years in a regulated industry, ideally medical devices.
- Knowledge of ISO 13485, ISO 14971, and MDR 2017/745.
- Excellent communication and stakeholder management skills.
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Staefa, Switzerland
(Senior) 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 (Senior), 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; German is a plus
