Design Quality Assurance Engineer (Senior)
Sonova Group
Who we are
You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Sonova. Create sense.
Staefa, Switzerland
Design Quality Assurance Engineer (Senior)
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
- Ensure compliance of R&D processes with internal and external regulations
- Support definition of user needs and design validation activities
- Support with design FMEA activities and to identify critical to quality attributes
- Support design control activities for new development projects (Hardware/Software)
- Perform risk management activities for assigned projects
- Collaborate with development teams to prevent/identify quality issues early
- Support design changes and post-launch improvements
- Contribute to process harmonization and standardization across R&D
- Assist with audits, NCs, CAPAs, and quality documentation as required
Your Profile
- 5+ years of 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, ISO 14971, and MDR 2017/745
- Hands-on experience with software development, IEC 62304/1, IEC60601 series is a plus
- Hands-on experience with design control, product risk management and design FMEA
- Excellent communication and stakeholder management skills
- Proficient in MS Office; experience with tools like Visio, Project, or Polarion is a plus
- Detail-oriented, organised, and confident in influencing without authority
- Fluent in English; German is a plus
Sonova is an equal opportunity employer.
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
