Design Quality Assurance Engineer

JoinSonova’s global qualityteam and play a keyrole in ensuringour innovative medicaldevicesmeetthehigheststandardsofsafety, performance, and compliance. As a Design Quality Assurance Engineer ,you’llpartnerwith R&D teamstoguideproductdevelopmentfromconceptto launch, ensuringregulatory excellence everystepoftheway

More abouttherole :

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 (., 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’recommitted 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.