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 safety, performance, 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:
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Act as Design Quality Assurance for SaMD, ensuring proper integration of third-party documentation into the internal QMS.
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Support remediation of external documentation to align with internal QMS processes and templates.
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Ensure cross-functional teams follow software development and quality requirements.
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Support risk management activities for assigned projects.
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Assist project teams in delivering compliant product launches and minimizing process deviations.
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Support design changes during development and post-launch.
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Proactively collaborate with development teams to prevent quality deviations.
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Support product reliability and improvement initiatives (e.g., FMEAs).
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Support process owners in creating and maintaining SOPs and driving process improvements.
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Support handling of NCs, CAPAs, and internal audits.
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Provide Design QA support for hardware products, as needed.
More about you:
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3+ years’ experience in quality roles, preferably in the medical device industry.
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Experience in QA for Software as a Medical Device (SaMD) development and risk management.
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Knowledge of ISO 13485, ISO 14971, and IEC 62304.
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Degree in Electronics, Software/ Mechanical Engineering, or a related technical field.
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Strong organizational skills, reliability, and attention to detail.
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Confident, communicative, and effective in cross-functional teams.
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Strong stakeholder management and quality partnership skills.
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Ability to explain regulatory requirements to non-experts.
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Proficient in English (written and spoken) and MS Office.
Nice to have :
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Experience in software usability engineering, software requirements, testing, and documentation.
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Knowledge of software verification and validation in regulated environments.
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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.