Karl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Vollzeitmit HomeofficeKeine Angabe
Tuttlingen
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KAKarl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Tuttlingen
Vollzeitmit Homeoffice
Nejo KI-Zusammenfassung
Optimizing PLM information structures and documentation for regulatory compliance in the healthcare sector. Proven knowledge of DHF, DMR, and global regulatory standards (ISO 13485, FDA) required. 30 vacation days, special payments.
Anforderungen
- Completed degree in natural sciences or engineering
- Proven knowledge of DHF, DMR, and global regulatory standards (e.g., ISO 13485, FDA)
- Ability to define, optimize, and maintain information structures and documentation processes in PLM
- Ability to organize documentation, prepare audits, ensure transparent project structure
- Confident manner as contact for auditors and project teams, including audit coordination and interdisciplinary collaboration
- Very good English skills
- In-depth knowledge of IEC 60601-1 and electronic components for medical device compliance
Aufgaben
- Continuously optimize PLM information structures.
- Continuously optimize PLM documentation processes.
- Continuously optimize PLM templates.
- Ensure regulatory compliance in PLM.
- Ensure operational efficiency in PLM.
- Maintain complete DHF and DMR.
- Ensure DHF and DMR accuracy.
- Ensure DHF and DMR compliance.
- Own Project Data Plan per regulatory standards.
- Own Phase Gate checklists per quality objectives.
- Develop lean, transparent, and comparable project structures.
- Maintain lean, transparent, and comparable project structures.
- Immediately report missing DHF/DMR elements.
- Immediately report time-critical DHF/DMR elements to project manager.
- Provide guidelines for updating legacy product documentation.
- Ensure efficient compliance for legacy products.
- Ensure project documents are complete.
- Ensure project documents are up-to-date.
- Ensure project documents are audit-compliant.
- Act as main contact for auditors.
- Coordinate audit preparation.
- Represent development projects during audits.
- Process anomalies from predecessor products.
- Process anomalies from similar products.
- Integrate safety into requirements management system.
- Integrate quality into requirements management system.
- Apply IEC 60601-1 standards.
- Apply knowledge of electronic components.
- Ensure electrical safety of medical devices.
- Ensure performance of medical devices.
- Ensure compliance of medical devices.
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- PLM
Benefits
Flexibles Arbeiten
- Hybrid work
- Flexible working hours
- Mobile working
Mehr Urlaubstage
- 30 vacation days
Boni & Prämien
- Special payments
Weiterbildungsangebote
- Further training opportunities
- In-house seminar program
- E-learning offering
- Professional development courses
Mitarbeiterrabatte
- Corporate benefits
Firmenfahrrad
- Bicycle leasing
Betriebliche Altersvorsorge
- Subsidy for private pension plan
Gesundheits- & Fitnessangebote
- Company health management
- Health activities
- Sports activities
Kinderbetreuung
- Childcare options
Team Events & Ausflüge
- Cultural activities
- Leisure activities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Karl Storz SE & Co. KG 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.
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Vollzeitmit HomeofficeBerufserfahrenTuttlingen
KAKarl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Tuttlingen
Vollzeitmit Homeoffice
Nejo KI-Zusammenfassung
Optimizing PLM information structures and documentation for regulatory compliance in the healthcare sector. Proven knowledge of DHF, DMR, and global regulatory standards (ISO 13485, FDA) required. 30 vacation days, special payments.
Anforderungen
- Completed degree in natural sciences or engineering
- Proven knowledge of DHF, DMR, and global regulatory standards (e.g., ISO 13485, FDA)
- Ability to define, optimize, and maintain information structures and documentation processes in PLM
- Ability to organize documentation, prepare audits, ensure transparent project structure
- Confident manner as contact for auditors and project teams, including audit coordination and interdisciplinary collaboration
- Very good English skills
- In-depth knowledge of IEC 60601-1 and electronic components for medical device compliance
Aufgaben
- Continuously optimize PLM information structures.
- Continuously optimize PLM documentation processes.
- Continuously optimize PLM templates.
- Ensure regulatory compliance in PLM.
- Ensure operational efficiency in PLM.
- Maintain complete DHF and DMR.
- Ensure DHF and DMR accuracy.
- Ensure DHF and DMR compliance.
- Own Project Data Plan per regulatory standards.
- Own Phase Gate checklists per quality objectives.
- Develop lean, transparent, and comparable project structures.
- Maintain lean, transparent, and comparable project structures.
- Immediately report missing DHF/DMR elements.
- Immediately report time-critical DHF/DMR elements to project manager.
- Provide guidelines for updating legacy product documentation.
- Ensure efficient compliance for legacy products.
- Ensure project documents are complete.
- Ensure project documents are up-to-date.
- Ensure project documents are audit-compliant.
- Act as main contact for auditors.
- Coordinate audit preparation.
- Represent development projects during audits.
- Process anomalies from predecessor products.
- Process anomalies from similar products.
- Integrate safety into requirements management system.
- Integrate quality into requirements management system.
- Apply IEC 60601-1 standards.
- Apply knowledge of electronic components.
- Ensure electrical safety of medical devices.
- Ensure performance of medical devices.
- Ensure compliance of medical devices.
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- PLM
Benefits
Flexibles Arbeiten
- Hybrid work
- Flexible working hours
- Mobile working
Mehr Urlaubstage
- 30 vacation days
Boni & Prämien
- Special payments
Weiterbildungsangebote
- Further training opportunities
- In-house seminar program
- E-learning offering
- Professional development courses
Mitarbeiterrabatte
- Corporate benefits
Firmenfahrrad
- Bicycle leasing
Betriebliche Altersvorsorge
- Subsidy for private pension plan
Gesundheits- & Fitnessangebote
- Company health management
- Health activities
- Sports activities
Kinderbetreuung
- Childcare options
Team Events & Ausflüge
- Cultural activities
- Leisure activities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Karl Storz SE & Co. KG 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
Karl Storz SE & Co. KG
Branche
Healthcare
Beschreibung
Das Unternehmen ermöglicht Karrieren und fördert langfristige Beziehungen.
Noch nicht perfekt?
- Karl Storz SE & Co. KG
Quality Engineer Medical Devices(m/w/x)
Vollzeitmit HomeofficeKeine AngabeTuttlingen - Karl Storz SE & Co. KG
Quality Engineer Digital OR(m/w/x)
Vollzeitmit HomeofficeKeine AngabeNeuhausen ob Eck - Karl Storz SE & Co. KG
SQA Engineer(m/w/x)
Vollzeitmit HomeofficeSeniorTuttlingen - KLS Martin Group
Quality Management Specialist(m/w/x)
Vollzeitmit HomeofficeKeine AngabeMühlheim an der Donau, Tuttlingen, Freiburg im Breisgau, Fridingen an der Donau - Aesculap AG
Software Requirements Engineer(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenTuttlingen