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