- 26.06.2025
- 90 - 100%
- Mitarbeiter
- Festanstellung
Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced Bionics and AudioNova - develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Design Quality Assurance Manager
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