Your personal AI career agent
Optimizing supplier qualification and documentation for medical devices treating aortic diseases. ISO 13485/9001 auditor qualification and 2+ years QM experience needed. Company pension scheme, EGYM Wellpass.
Requirements
- Scientific/technical/medical degree with 2 years QM experience or education with 4 years QM experience
- Experience in Quality Management Systems (ISO 13485)
- Experience in supplier management and first article inspections
- Qualification as auditor for ISO 13485 and ISO 9001
- Analytical, methodical, and critical mindset
- Strong written and verbal communication skills
- Good documentation skills for complex tasks
- Strong coordination skills
- Structured, conscientious, and reliable working style
- High attention to detail and willingness to learn
Tasks
- Maintain and improve the supplier master file
- Optimize supplier qualification and evaluation processes
- Coordinate all supplier qualification activities
- Manage the approved supplier and service provider list
- Review supplier documentation for completeness and traceability
- Compare supplier specifications with internal requirements
- Approve suppliers for criticality classes 1 and 2
- Develop and coordinate Quality Assurance Agreements
- Prepare, support, and follow up on supplier audits
- Support CAPA measures and nonconformity reports
- Manage change requests resulting from nonconformities
- Review and request updated supplier certificates monthly
- Participate in NC and change boards
- Execute and document first article inspections
- Verify first article characteristics against technical drawings
- Evaluate externally performed first article inspections
- Plan incoming goods inspection steps with QC
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- ISO 9001
Benefits
Informal Culture
- International team
Purpose-Driven Work
- High responsibility role
Flexible Working
- Flexible working conditions
Retirement Plans
- Company pension scheme
Healthcare & Fitness
- EGYM Wellpass
Startup Environment
- Cross-functional collaboration
Learning & Development
- Professional development opportunities
- Home
- Jobs in Germany
- Supplier Quality EngineerSupplier Quality Engineer at Jotec
Not a perfect match?
- ArtivionFull-timeWorking StudentOn-siteHechingenfrom 15 / hour
- Jotec
Endovascular Product Specialist(m/w/x)
Full-timeOn-siteNot specifiedHechingen - Gebrüder Frei GmbH & Co. KG
Mitarbeiter im Qualitätswesen(m/w/x)
Full-timeOn-siteCareer ChangerAlbstadt - Gebrüder Frei GmbH & Co. KG
Qualitätsplaner(m/w/x)
Full-timeOn-siteSeniorAlbstadt - MEDIRA GmbH
Produktionsmitarbeiter Nähen Implantat(m/w/x)
Full-timeOn-siteExperiencedBalingen
- Home
- Jobs in Germany
- Supplier Quality EngineerSupplier Quality Engineer at Jotec
Optimizing supplier qualification and documentation for medical devices treating aortic diseases. ISO 13485/9001 auditor qualification and 2+ years QM experience needed. Company pension scheme, EGYM Wellpass.
Requirements
- Scientific/technical/medical degree with 2 years QM experience or education with 4 years QM experience
- Experience in Quality Management Systems (ISO 13485)
- Experience in supplier management and first article inspections
- Qualification as auditor for ISO 13485 and ISO 9001
- Analytical, methodical, and critical mindset
- Strong written and verbal communication skills
- Good documentation skills for complex tasks
- Strong coordination skills
- Structured, conscientious, and reliable working style
- High attention to detail and willingness to learn
Tasks
- Maintain and improve the supplier master file
- Optimize supplier qualification and evaluation processes
- Coordinate all supplier qualification activities
- Manage the approved supplier and service provider list
- Review supplier documentation for completeness and traceability
- Compare supplier specifications with internal requirements
- Approve suppliers for criticality classes 1 and 2
- Develop and coordinate Quality Assurance Agreements
- Prepare, support, and follow up on supplier audits
- Support CAPA measures and nonconformity reports
- Manage change requests resulting from nonconformities
- Review and request updated supplier certificates monthly
- Participate in NC and change boards
- Execute and document first article inspections
- Verify first article characteristics against technical drawings
- Evaluate externally performed first article inspections
- Plan incoming goods inspection steps with QC
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- ISO 9001
Benefits
Informal Culture
- International team
Purpose-Driven Work
- High responsibility role
Flexible Working
- Flexible working conditions
Retirement Plans
- Company pension scheme
Healthcare & Fitness
- EGYM Wellpass
Startup Environment
- Cross-functional collaboration
Learning & Development
- Professional development opportunities
About the Company
Jotec
Industry
Healthcare
Description
Das Unternehmen stellt hochwertige Produkte und Lösungen zur Behandlung von Aortenerkrankungen her.
Not a perfect match?
- Artivion
Working Student Sustaining Engineering(m/w/x)
Full-timeWorking StudentOn-siteHechingenfrom 15 / hour - Jotec
Endovascular Product Specialist(m/w/x)
Full-timeOn-siteNot specifiedHechingen - Gebrüder Frei GmbH & Co. KG
Mitarbeiter im Qualitätswesen(m/w/x)
Full-timeOn-siteCareer ChangerAlbstadt - Gebrüder Frei GmbH & Co. KG
Qualitätsplaner(m/w/x)
Full-timeOn-siteSeniorAlbstadt - MEDIRA GmbH
Produktionsmitarbeiter Nähen Implantat(m/w/x)
Full-timeOn-siteExperiencedBalingen