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Sonova AG
10d ago

Design Quality Assurance Engineer(m/w/x)

Stäfa
Full-timeOn-siteExperienced

Description

You will ensure regulatory excellence by guiding R&D teams through the development of innovative medical devices, from initial concept to compliant product launches and post-market improvements.

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Requirements

  • 3+ years experience in quality roles
  • Experience in SaMD QA and risk management
  • Knowledge of ISO 13485, 14971, and 62304
  • Degree in Engineering or related field
  • Strong organization, reliability, and detail orientation
  • Confidence, communication, and cross-functional effectiveness
  • Strong stakeholder management and quality partnership
  • Ability to explain regulations to non-experts
  • Proficiency in English and MS Office
  • Experience in software usability and documentation
  • Knowledge of software verification and validation
  • Familiarity with SDLC and quality gates

Education

Bachelor's degree

Work Experience

3 years

Tasks

  • Serve as Design Quality Assurance for SaMD
  • Integrate third-party documentation into the internal QMS
  • Remediate external documentation to align with internal templates
  • Guide cross-functional teams on software development requirements
  • Support risk management activities for assigned projects
  • Assist teams in delivering compliant product launches
  • Minimize process deviations during development
  • Manage design changes during and after launch
  • Collaborate with developers to prevent quality deviations
  • Support product reliability and FMEA initiatives
  • Create and maintain SOPs with process owners
  • Drive continuous process improvements
  • Handle NCs, CAPAs, and internal audits
  • Provide Design QA support for hardware products

Tools & Technologies

ISO 13485ISO 14971IEC 62304MS OfficeSDLC

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Flexible hybrid working model

Learning & Development

  • Professional and personal development
  • Individual development plans

Career Advancement

  • Exceptional growth opportunities
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