Aktuelle Jobs im Zusammenhang mit Design Quality Assurance Expert - Schweinfurt - Fresenius Medical Care
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Design Quality Assurance Expert
vor 3 Wochen
Schweinfurt, Bayern, Deutschland Fresenius Medical Care VollzeitÜberblickFresenius Medical Care ist ein weltweit führendes Unternehmen im Bereich der Medizintechnik. Wir suchen nach einem erfahrenen Design Quality Assurance Expert, der unsere Qualitätsstandards in der Entwicklung von Medizinprodukten sicherstellt.AufgabenSicherstellung der Einhaltung von Qualitätsstandards: Der Design Quality Assurance Expert ist...
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Design Quality Assurance Expert
vor 4 Monaten
Schweinfurt, Deutschland Fresenius Medical Care VollzeitThis role combines the Design Quality Assurance and the Product Center Manager role**. **In your role as **Design Quality Assurance Expert** (M/F/d) you will be working as a part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients. In addition, the...
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Quality Assurance Expert
vor 4 Monaten
Schweinfurt, Deutschland Fresenius Medical Care VollzeitIn Ihrer Rolle als Quality Assurance Expert (M/F/d) sind Sie für die Sicherstellung der Qualität von Design Control-Aktivitäten für aktive Medizinprodukte, sowie Unterstützung der Design und Development Projekte zur korrekten Umsetzung der Produktentwicklungsprozesse und Einhaltung aller spezifischen Anforderungen und geltenden Normen...
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Design Quality Assurance Expert
vor 2 Monaten
Schweinfurt, Deutschland Fresenius Medical Care VollzeitFresenius Medical Care ist der weltweit führende Anbieter von Produkten und Dienstleistungen für Menschen mit Nierenerkrankungen. Als globales Gesundheitsunternehmen haben wir einen besonderen Auftrag: die bestmögliche Versorgung zu gewährleisten. Helfen Sie uns, die Lebensqualität einer wachsenden Zahl von Patienten auf der ganzen Welt zu...
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Design Quality Assurance Expert
vor 3 Wochen
Schweinfurt, Bayern, Deutschland Fresenius Medical Care VollzeitÜberblickFresenius Medical Care ist ein führender Anbieter von Produkten und Dienstleistungen für Menschen mit Nierenkrankheiten. Wir suchen nach einem erfahrenen Qualitätsassistenten, der unsere Qualitätsstandards in der Medizintechnik sicherstellt.Ihre AufgabenQualitätskontrolle: Sie sind verantwortlich für die Überprüfung von Design- und...
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**Quality Assurance Specialist**
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Engineer
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Quality Assurance Engineer
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Senior Quality Assurance Specialist
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Senior Quality Assurance Specialist
vor 2 Wochen
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Quality Assurance Manager
vor 1 Monat
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Nursing Assistant with Quality Assurance Experience
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Nursing Assistant with Quality Assurance Experience
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Quality Assurance Engineer
vor 3 Wochen
Schweinfurt, Bayern, Deutschland Schaeffler VollzeitAbout the RoleSchaeffler is a global technology company that combines the fascination of an international corporation with the culture of a family-owned business. As a partner to major automobile manufacturers and numerous industrial customers, we offer a wide range of opportunities for personal development.Your ResponsibilitiesAcceptance of manufactured...
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Quality Assurance Engineer
vor 2 Wochen
Schweinfurt, Bayern, Deutschland Schaeffler VollzeitAbout the RoleSchaeffler is a global technology company that combines the fascination of an international corporation with the culture of a family-owned business. As a partner to major automobile manufacturers and numerous industrial customers, we offer a wide range of opportunities for personal development.Your ResponsibilitiesAcceptance of manufactured...
Design Quality Assurance Expert
vor 5 Monaten
The Design Quality Assurance Expert (m/w/d) will be responsible to ensure the quality of design control activities for Active Medical Devices, supporting the project design and development to correctly realizing product development processes and complying with all specific requirements and applicable standards.
**Your assignments**:
- Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs
- Provides input and guidance to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Design Quality
- Review and approve all product development and change management projects compliance with Fresenius Quality Management System / SOP requirements by:
- Review and approval of design control documentation
- Design Review, Phase Exit Review and Milestone approval
- Sample review of design control documentation during project execution
- Independent compliance check through regular corporate audits
- Creation and monitoring of compliance metrics of design controls in development and design change activities
- Providing Management / Quality Review input for design & development
**Your profile**:
- Successfully completed university degree in a technical or scientific field, such as medical technology
- Several years of professional experience in research and development, regulatory affairs or quality management for medical devices or pharmaceuticals
- Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
- Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR -820.250, etc.)
- Knowledge of CAPA methodology
- Excellent presentation and communication skills (fluent written and spoken English skills, German is an advantage), high engagement on achieving the targets and on the objectives, independent working structure