Join Sonovas 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 youll partner with R&D teams to guide product development from concept to launch ensuring regulatory excellence every step of the way.
Key Responsibilities
- Support design control activities for new development projects (Hardware/Software)
- Perform risk management activities for assigned projects
- Support with design FMEA activities
- Actively collaborate with cross-functional development teams
- Support design changes and post-launch improvements
- Contribute in continuous improvement projects
Your Profile
- Proven practical experience in a regulated industry preferably medical devices
- Bachelors or masters degree in engineering science quality is a plus
- Knowledge of ISO 13485 and ISO 14971
- Hands-on experience with design control product risk management and design FMEA
- Hands-on experience with software development IEC 62304/1 IEC60601 series is a plus
- Proficient in MS Office; experience with tools like Visio Project or Polarion is a plus
- Fluent in English