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Design Quality Assurance Engineer(m/w/x)
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
Languages
English – Business Fluent
Benefits
Flexible Working
- •Flexible hybrid working model
Learning & Development
- •Professional and personal development
- •Individual development plans
Career Advancement
- •Exceptional growth opportunities
- Tecan Trading AGFull-timeOn-siteExperiencedMännedorf
- HUBER+SUHNER
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Design Quality Assurance Engineer(m/w/x)
The AI Job Search Engine
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
Languages
English – Business Fluent
Benefits
Flexible Working
- •Flexible hybrid working model
Learning & Development
- •Professional and personal development
- •Individual development plans
Career Advancement
- •Exceptional growth opportunities
About the Company
Sonova AG
Industry
Healthcare
Description
The company builds systems to render speech clear and free of noise using deep learning technology, empowering people with hearing loss.
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Full-timeOn-siteExperiencedPfäffikon SZ - Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Full-timeOn-siteSeniorZug, Steinhausen - Octapharma
Group Senior Analyst Quality Applications(m/w/x)
Full-timeOn-siteSeniorLachen - NL3M Philips International BV
Patient Safety and Quality Leader DACH(m/w/x)
Full-timeOn-siteManagementHorgen