eResearchTechnology GmbH
Lead Engineer, R&D Software Quality(m/w/x)
Vollzeitnur vor OrtManagement
Estenfeld
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
CLClario
Sr Product Quality Engineer(m/w/x)
Estenfeld
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Ensuring medical devices and solutions meet global regulations and QMS compliance. 5+ years in GMP/GCP regulated environments required. Flexible working hours, professional development support.
Anforderungen
- Bachelor’s degree in Engineering, Life Sciences, or equivalent
- At least 5 years of Design Controls or Quality Management Systems experience
- At least 5 years of GMP and/or GCP regulated environments experience
- Agile development support in regulated environment experience
- Minimum 2 years of ISO and/or GCP standards experience
- Auditor experience in GCP/GMP environment preferred
- Strong troubleshooting, communication, and stakeholder management skills
- Professional working proficiency in English
- Willingness to travel internationally
Aufgaben
- Establish and maintain Clario's Quality Management System (QMS)
- Continuously improve Clario's Quality Management System (QMS)
- Provide quality and regulatory expertise
- Ensure devices and solutions meet global regulations
- Ensure compliance with control processes across projects
- Review development and technical documentation
- Provide quality and regulatory guidance
- Ensure medical and non-medical devices comply with regulations
- Contribute to product reviews
- Contribute to design control activities
- Support validation activities
- Resolve quality issues with internal departments
- Support continuous improvement initiatives
- Support the Quality Management designee
- Participate in quality surveillance activities
- Support revision of procedures and policies
- Support maintenance of procedures and policies
- Support internal audit activities
- Support external audit activities
- Serve as a member of the Designated Complaint Unit (DCU)
- Fulfill DCU responsibilities
- Report project status to management
- Report project risks to management
- Report project deviations to management
- Report quality concerns to management
- Recommend corrective actions
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible working hours
Familienfreundlichkeit
- Work-life balance support
Weiterbildungsangebote
- Professional development support
- Internal and external training
- Certification programs
Sonstige Vorteile
- Employee programs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Clario 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- eResearchTechnology GmbH
Technical Product Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenEstenfeld - eResearchTechnology GmbH
Facilities Manager Europe(m/w/x)
Vollzeitnur vor OrtSeniorEstenfeld - DE1645 Prysmian Projects Germany GmbH
Project Quality Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWürzburg - Bertrandt
Systemtestingenieur in der Medizintechnik(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWürzburg
CLClario
Sr Product Quality Engineer(m/w/x)
Estenfeld
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Ensuring medical devices and solutions meet global regulations and QMS compliance. 5+ years in GMP/GCP regulated environments required. Flexible working hours, professional development support.
Anforderungen
- Bachelor’s degree in Engineering, Life Sciences, or equivalent
- At least 5 years of Design Controls or Quality Management Systems experience
- At least 5 years of GMP and/or GCP regulated environments experience
- Agile development support in regulated environment experience
- Minimum 2 years of ISO and/or GCP standards experience
- Auditor experience in GCP/GMP environment preferred
- Strong troubleshooting, communication, and stakeholder management skills
- Professional working proficiency in English
- Willingness to travel internationally
Aufgaben
- Establish and maintain Clario's Quality Management System (QMS)
- Continuously improve Clario's Quality Management System (QMS)
- Provide quality and regulatory expertise
- Ensure devices and solutions meet global regulations
- Ensure compliance with control processes across projects
- Review development and technical documentation
- Provide quality and regulatory guidance
- Ensure medical and non-medical devices comply with regulations
- Contribute to product reviews
- Contribute to design control activities
- Support validation activities
- Resolve quality issues with internal departments
- Support continuous improvement initiatives
- Support the Quality Management designee
- Participate in quality surveillance activities
- Support revision of procedures and policies
- Support maintenance of procedures and policies
- Support internal audit activities
- Support external audit activities
- Serve as a member of the Designated Complaint Unit (DCU)
- Fulfill DCU responsibilities
- Report project status to management
- Report project risks to management
- Report project deviations to management
- Report quality concerns to management
- Recommend corrective actions
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible working hours
Familienfreundlichkeit
- Work-life balance support
Weiterbildungsangebote
- Professional development support
- Internal and external training
- Certification programs
Sonstige Vorteile
- Employee programs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Clario 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Clario
Branche
Healthcare
Beschreibung
The company transforms lives by unlocking better evidence to advance clinical science and bring life-changing therapies to patients faster.
Noch nicht perfekt?
- eResearchTechnology GmbH
Lead Engineer, R&D Software Quality(m/w/x)
Vollzeitnur vor OrtManagementEstenfeld - eResearchTechnology GmbH
Technical Product Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenEstenfeld - eResearchTechnology GmbH
Facilities Manager Europe(m/w/x)
Vollzeitnur vor OrtSeniorEstenfeld - DE1645 Prysmian Projects Germany GmbH
Project Quality Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWürzburg - Bertrandt
Systemtestingenieur in der Medizintechnik(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWürzburg