CVS engineering GmbH
Supplier Quality Engineer(m/w/x)
Vollzeitnur vor OrtManagement
Rheinfelden (Baden)
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
RORoche
Device Supplier Quality Manager(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Quality assurance oversight for external GxP suppliers of medical devices and combination products at global biotechnology firm. Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971 required. International collaboration with GxP suppliers.
Anforderungen
- Engineering or Science degree
- Thorough understanding of biotechnology industry, combination products, medical devices
- Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971
- Sound understanding of Quality Compliance, Quality Engineering, Audits & Inspections Management
- Ability to educate on Design Controls (medical devices, combination products)
- Demonstrated capability in risk management concepts and tools
- Well-developed teamwork and collaboration skills
- Clear, professional verbal and written communication
- Fluency in English
- Fluency in a second language (plus)
- Demonstrated problem solving and decision-making skills
- Hands-on experience with quality-related tools, Six Sigma / DMAIC
- Experience in agile environment
- Usage of lean tools
Aufgaben
- Provide quality assurance oversight for external GxP suppliers.
- Ensure medical device and combination product compliance with regulations, standards, and Roche requirements.
- Oversee quality activities throughout the GxP supplier lifecycle.
- Manage method validation processes.
- Coordinate Roche and Health Authority audits.
- Oversee complaint handling procedures.
- Manage regulatory submissions.
- Serve as SME for supplier qualification audits.
- Serve as SME for supplier maintenance audits.
- Perform quality assurance for supplier change controls and deviations.
- Facilitate systematic root cause assessments (RCA).
- Coordinate quality support for medical devices and combination products.
- Collaborate with local QA/QC teams on clinical and commercial release.
- Set work priorities for project targets and timelines.
- Maintain up-to-date job-related training status.
- Improve knowledge and skills in quality, compliance, and technology.
- Notify management of potential quality or regulatory issues.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 13485
- 21 CFR 820
- EU MDR
- ISO 14971
- Six Sigma
- DMAIC
- Lean tools
- Agile
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche 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?
- Roche
Direct Material Sciences Specialist/Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Validation Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKaiseraugst - F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Vollzeitnur vor OrtSeniorBasel - ten23 health
QA for QC Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBasel
RORoche
Device Supplier Quality Manager(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Quality assurance oversight for external GxP suppliers of medical devices and combination products at global biotechnology firm. Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971 required. International collaboration with GxP suppliers.
Anforderungen
- Engineering or Science degree
- Thorough understanding of biotechnology industry, combination products, medical devices
- Working knowledge of ISO 13485, 21 CFR 820, EU MDR, ISO 14971
- Sound understanding of Quality Compliance, Quality Engineering, Audits & Inspections Management
- Ability to educate on Design Controls (medical devices, combination products)
- Demonstrated capability in risk management concepts and tools
- Well-developed teamwork and collaboration skills
- Clear, professional verbal and written communication
- Fluency in English
- Fluency in a second language (plus)
- Demonstrated problem solving and decision-making skills
- Hands-on experience with quality-related tools, Six Sigma / DMAIC
- Experience in agile environment
- Usage of lean tools
Aufgaben
- Provide quality assurance oversight for external GxP suppliers.
- Ensure medical device and combination product compliance with regulations, standards, and Roche requirements.
- Oversee quality activities throughout the GxP supplier lifecycle.
- Manage method validation processes.
- Coordinate Roche and Health Authority audits.
- Oversee complaint handling procedures.
- Manage regulatory submissions.
- Serve as SME for supplier qualification audits.
- Serve as SME for supplier maintenance audits.
- Perform quality assurance for supplier change controls and deviations.
- Facilitate systematic root cause assessments (RCA).
- Coordinate quality support for medical devices and combination products.
- Collaborate with local QA/QC teams on clinical and commercial release.
- Set work priorities for project targets and timelines.
- Maintain up-to-date job-related training status.
- Improve knowledge and skills in quality, compliance, and technology.
- Notify management of potential quality or regulatory issues.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 13485
- 21 CFR 820
- EU MDR
- ISO 14971
- Six Sigma
- DMAIC
- Lean tools
- Agile
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche 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
Roche
Branche
Healthcare
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- CVS engineering GmbH
Supplier Quality Engineer(m/w/x)
Vollzeitnur vor OrtManagementRheinfelden (Baden) - Roche
Direct Material Sciences Specialist/Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Validation Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKaiseraugst - F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Vollzeitnur vor OrtSeniorBasel - ten23 health
QA for QC Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBasel