Software Tester ensuring high software quality standards through testing applications and collaborating in agile teams. Involved in test case development and automation using modern tools and methodologies.
About the role
- Design Quality Assurance Engineer ensuring regulatory excellence and quality standards for innovative medical devices at Sonova. Collaborating with R&D teams from concept to launch.
Responsibilities
- 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
Requirements
- 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
Benefits
- Flexible hybrid working model
- Wide range of training opportunities for professional and personal development
- Exceptional growth opportunities with individual development plans
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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