Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Full-timeOn-siteSenior
Zug, Steinhausen
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SOSonova AG
Design Quality Assurance Engineer(m/w/x)
Stäfa
Full-timeOn-siteExperienced
Nejo AI Summary
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.
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
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
Work Experience
3 years
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
ISO 13485ISO 14971IEC 62304MS OfficeSDLC
Benefits
Flexible Working
- •Flexible hybrid working model
Learning & Development
- •Professional and personal development
- •Individual development plans
Career Advancement
- •Exceptional growth opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sonova AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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SOSonova AG
Design Quality Assurance Engineer(m/w/x)
Stäfa
Full-timeOn-siteExperienced
Nejo AI Summary
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.
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
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
Work Experience
3 years
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
ISO 13485ISO 14971IEC 62304MS OfficeSDLC
Benefits
Flexible Working
- •Flexible hybrid working model
Learning & Development
- •Professional and personal development
- •Individual development plans
Career Advancement
- •Exceptional growth opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sonova AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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.
Not a perfect match?
- Viatris Pharma GmbH
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Full-timeOn-siteSeniorZug, Steinhausen - Octapharma
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Full-timeOn-siteSeniorLachen - The Kusnacht Practice AG
Clinical Quality, Process & Medical Procurement Specialist(m/w/x)
Full-timeOn-siteSeniorZollikon - NL3M Philips International BV
Patient Safety and Quality Leader DACH(m/w/x)
Full-timeOn-siteManagementHorgen - Viatris Pharma GmbH
Manager Quality Assurance(m/w/x)
Full-timeOn-siteManagementZug