Ketryx
Head of Software Testing(m/w/x)
Vollzeitmit HomeofficeSenior
Wien
ab 100.000 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
KEKetryx
QA/RA Lead(m/w/x)
Wien
ab 90.000 / Jahr
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
QMS setup and deployment for medical software clients, consulting on ISO 13485 and EU MDR. 4-8 years in quality systems management for medical software required. Generous stock options.
Anforderungen
- 4-8 years experience in quality systems management, management representative or senior specialist role
- Familiarity with eQMS implementation, validation
- Deep expertise in QMS setup, sub-systems, implementation
- Strong knowledge of ISO 13485 and Global QMS
- Expertise in AI, Digital, SaMD, Cyber Compliance (SOC 2, ISO 27001)
- Deep understanding of medical device cybersecurity
- Experience as QMS representative in regulated environments
- Proven experience managing audit lifecycles
- Familiarity with continuous validation methodologies (CSV, GAMP 5, ISO 13485) and documentation
- Experience with regulatory and Notified Body submission
- Background in medical device industry quality systems
- Ability to work independently and own complex regulatory projects
- Proven track record in consulting or client-facing roles
- Experience at large medical device companies
- Background with consulting firms specializing in QMS setup
- Startup experience (Series A/B) with QMS implementation
- Specializations in cybersecurity, usability, or computer software validation
- Experience scaling quality operations in high-growth environments
- Knowledge of AI applications in regulatory affairs
- Submission experience
Aufgaben
- Lead QMS setup and deployment for medical device clients
- Own and manage QMS templates and compliance frameworks
- Consult on ISO 13485, EU MDR/IVDR, UKCA, GxP
- Scale operations for high-growth clients
- Develop repeatable QMS deployment processes
- Leverage AI for automatic compliance
- Drive and support internal and external audit programs
- Manage customer audits
- Oversee regulatory inspections
- Orchestrate continuous validation lifecycle
- Draft, review, and approve documentation
- Ensure real-time compliance program management
- Shape regulatory affairs through innovative product development
- Work independently on complex QA projects
- Ensure customer success throughout engagement lifecycle
Berufserfahrung
- 4 - 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- eQMS
- ISO 13485
- AI
- Digital
- SaMD
- SOC 2
- ISO 27001
- CSV
- GAMP 5
Benefits
Boni & Prämien
- Performance-based bonus
Attraktive Vergütung
- Equity options
- Competitive compensation
- Generous stock options
Flexibles Arbeiten
- WFH option
Mehr Urlaubstage
- Generous PTO for full-time
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Ketryx 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?
- Flinn.ai
Senior Regulatory Affairs Specialist(m/w/x)
Vollzeitmit HomeofficeSeniorWien, Berlin - Ketryx
Software Quality Engineer(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 80.000 / Jahr - Nagarro
Senior QA Lead(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 5.500 - 8.000 / Monat
KEKetryx
QA/RA Lead(m/w/x)
Wien
ab 90.000 / Jahr
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
QMS setup and deployment for medical software clients, consulting on ISO 13485 and EU MDR. 4-8 years in quality systems management for medical software required. Generous stock options.
Anforderungen
- 4-8 years experience in quality systems management, management representative or senior specialist role
- Familiarity with eQMS implementation, validation
- Deep expertise in QMS setup, sub-systems, implementation
- Strong knowledge of ISO 13485 and Global QMS
- Expertise in AI, Digital, SaMD, Cyber Compliance (SOC 2, ISO 27001)
- Deep understanding of medical device cybersecurity
- Experience as QMS representative in regulated environments
- Proven experience managing audit lifecycles
- Familiarity with continuous validation methodologies (CSV, GAMP 5, ISO 13485) and documentation
- Experience with regulatory and Notified Body submission
- Background in medical device industry quality systems
- Ability to work independently and own complex regulatory projects
- Proven track record in consulting or client-facing roles
- Experience at large medical device companies
- Background with consulting firms specializing in QMS setup
- Startup experience (Series A/B) with QMS implementation
- Specializations in cybersecurity, usability, or computer software validation
- Experience scaling quality operations in high-growth environments
- Knowledge of AI applications in regulatory affairs
- Submission experience
Aufgaben
- Lead QMS setup and deployment for medical device clients
- Own and manage QMS templates and compliance frameworks
- Consult on ISO 13485, EU MDR/IVDR, UKCA, GxP
- Scale operations for high-growth clients
- Develop repeatable QMS deployment processes
- Leverage AI for automatic compliance
- Drive and support internal and external audit programs
- Manage customer audits
- Oversee regulatory inspections
- Orchestrate continuous validation lifecycle
- Draft, review, and approve documentation
- Ensure real-time compliance program management
- Shape regulatory affairs through innovative product development
- Work independently on complex QA projects
- Ensure customer success throughout engagement lifecycle
Berufserfahrung
- 4 - 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- eQMS
- ISO 13485
- AI
- Digital
- SaMD
- SOC 2
- ISO 27001
- CSV
- GAMP 5
Benefits
Boni & Prämien
- Performance-based bonus
Attraktive Vergütung
- Equity options
- Competitive compensation
- Generous stock options
Flexibles Arbeiten
- WFH option
Mehr Urlaubstage
- Generous PTO for full-time
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Ketryx 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
Ketryx
Branche
Healthcare
Beschreibung
Ketryx is saving and improving lives by making medical software safe and reliable. It empowers software teams to create compliant products.
Noch nicht perfekt?
- Ketryx
Head of Software Testing(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 100.000 / Jahr - Flinn.ai
Senior Regulatory Affairs Specialist(m/w/x)
Vollzeitmit HomeofficeSeniorWien, Berlin - Ketryx
Software Quality Engineer(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 80.000 / Jahr - Nagarro
Senior QA Lead(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 5.500 - 8.000 / Monat