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
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