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
1. Ensure compliance of R&D processes with internal and external regulations
2. Support definition of user needs and design validation activities
3. Support with design FMEA activities and to identify critical to quality attributes
4. Support design control activities for new development projects (Hardware/Software)
5. Perform risk management activities for assigned projects
6. Collaborate with development teams to prevent/identify quality issues early
7. Support design changes and post-launch improvements
8. Contribute to process harmonization and standardization across R&D
9. Assist with audits, NCs, CAPAs, and quality documentation as required
Your Profile
10. 5+ years of experience in a regulated industry, preferably medical devices
11. Bachelor’s or master’s degree in engineering, science, quality is a plus
12. Knowledge of ISO 13485, ISO 14971, and MDR 2017/745
13. Hands-on experience with software development, IEC 62304/1, IEC60601 series is a plus
14. Hands-on experience with design control, product risk management and design FMEA
15. Excellent communication and stakeholder management skills
16. Proficient in MS Office; experience with tools like Visio, Project, or Polarion is a plus
17. Detail-oriented, organised, and confident in influencing without authority
18. Fluent in English; German is a plus