Gebrüder Frei GmbH & Co. KG
Mitarbeiter im Qualitätswesen(m/w/x)
Full-timeOn-siteCareer Changer
Albstadt
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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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Jotec and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Jotec and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Jotec
Industry
Healthcare
Description
Das Unternehmen stellt hochwertige Produkte und Lösungen zur Behandlung von Aortenerkrankungen her.
Not a perfect match?
- Gebrüder Frei GmbH & Co. KG
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Full-timeWorking StudentOn-siteHechingenfrom 15 / hour - BOWA-DE
QS-Mitarbeiter:innen Elektronik(m/w/x)
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Mitarbeiter Qualitätssicherung(m/w/x)
Full-timeOn-siteExperiencedTübingen