Sonova Group

Design Quality Assurance Engineer

Sonova Group

full-time

Posted on:

Location Type: Hybrid

Location: Staefa • Switzerland

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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

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assurancerisk managementFMEAsSOPsSaMD developmentISO 13485ISO 14971IEC 62304documentation remediationprocess improvements
Soft Skills
organizational skillsattention to detailcommunication skillsstakeholder managementcross-functional collaborationreliabilityquality partnershipexplanation of regulatory requirements