Who we are

At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change, 

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Staefa, Switzerland

Design Quality Assurance Engineer

Join Sonova’s global quality team and play a key role in ensuring our innovative medical devices meet the highest standards of safetyperformance, and compliance. As a Design Quality Assurance Engineer , you’ll partner with R&D teams to guide product development from concept to launch, ensuring regulatory excellence every step of the way 

 

More about the role 

 

  • Act as Design Quality Assurance for SaMD, ensuring proper integration of third-party documentation into the internal QMS. 

  • Support remediation of external documentation to align with internal QMS processes and templates. 

  • Ensure cross-functional teams follow software development and quality requirements. 

  • Support risk management activities for assigned projects. 

  • Assist project teams in delivering compliant product launches and minimizing process deviations. 

  • Support design changes during development and post-launch. 

  • Proactively collaborate with development teams to prevent quality deviations. 

  • Support product reliability and improvement initiatives (e.g., FMEAs). 

  • Support process owners in creating and maintaining SOPs and driving process improvements. 

  • Support handling of NCs, CAPAs, and internal audits. 

  • Provide Design QA support for hardware products, as needed. 

 

More about you:  

 

  • 3+ years’ experience in quality roles, preferably in the medical device industry. 

  • Experience in QA for Software as a Medical Device (SaMD) development and risk management. 

  • Knowledge of ISO 13485, ISO 14971, and IEC 62304. 

  • Degree in Electronics, Software/ Mechanical Engineering, or a related technical field. 

  • Strong organizational skills, reliability, and attention to detail. 

  • Confident, communicative, and effective in cross-functional teams. 

  • Strong stakeholder management and quality partnership skills. 

  • Ability to explain regulatory requirements to non-experts. 

  • Proficient in English (written and spoken) and MS Office. 

Nice to have : 

  • Experience in software usability engineering, software requirements, testing, and documentation. 

  • Knowledge of software verification and validation in regulated environments. 

  • Familiarity with SDLC processes and quality gates. 

 

 

More about what we offer:  

 

As one of the world’s leading hearing care providers headquartered in Switzerland, we’re committed to building an inclusive culture. We want to create an environment where you can balance a successful career with your commitments and interests outside of work, through our flexible hybrid working model. We offer a wide range of training opportunities for both your professional and personal development, and there are exceptional growth opportunities with individual development plans. 

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.

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