Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Vollzeitnur vor OrtSenior
Zug, Steinhausen
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
SOSonova AG
Design Quality Assurance Engineer(m/w/x)
Stäfa
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
3 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
ISO 13485ISO 14971IEC 62304MS OfficeSDLC
Benefits
Flexibles Arbeiten
- •Flexible hybrid working model
Weiterbildungsangebote
- •Professional and personal development
- •Individual development plans
Karriere- und Weiterentwicklung
- •Exceptional growth opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sonova AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- The Kusnacht Practice AG
Clinical Quality, Process & Medical Procurement Specialist(m/w/x)
Vollzeitnur vor OrtSeniorZollikon - NL3M Philips International BV
Patient Safety and Quality Leader DACH(m/w/x)
Vollzeitnur vor OrtManagementHorgen - Octapharma
Group Senior Analyst Quality Applications(m/w/x)
Vollzeitnur vor OrtSeniorLachen - Viatris Pharma GmbH
Manager Quality Assurance(m/w/x)
Vollzeitnur vor OrtManagementZug
SOSonova AG
Design Quality Assurance Engineer(m/w/x)
Stäfa
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
3 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
ISO 13485ISO 14971IEC 62304MS OfficeSDLC
Benefits
Flexibles Arbeiten
- •Flexible hybrid working model
Weiterbildungsangebote
- •Professional and personal development
- •Individual development plans
Karriere- und Weiterentwicklung
- •Exceptional growth opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sonova AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Sonova AG
Branche
Healthcare
Beschreibung
The company builds systems to render speech clear and free of noise using deep learning technology, empowering people with hearing loss.
Noch nicht perfekt?
- Viatris Pharma GmbH
Head of Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorZug, Steinhausen - The Kusnacht Practice AG
Clinical Quality, Process & Medical Procurement Specialist(m/w/x)
Vollzeitnur vor OrtSeniorZollikon - NL3M Philips International BV
Patient Safety and Quality Leader DACH(m/w/x)
Vollzeitnur vor OrtManagementHorgen - Octapharma
Group Senior Analyst Quality Applications(m/w/x)
Vollzeitnur vor OrtSeniorLachen - Viatris Pharma GmbH
Manager Quality Assurance(m/w/x)
Vollzeitnur vor OrtManagementZug