ZELTWANGER Maschinenbau GmbH
Mitarbeiter Qualitätssicherung(m/w/x)
Full-timeOn-siteExperienced
Tübingen
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You will ensure the highest quality standards by managing supplier qualifications and audits, playing a vital role in the production of life-saving medical solutions for aortic diseases.
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
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
ISO 13485ISO 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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You will ensure the highest quality standards by managing supplier qualifications and audits, playing a vital role in the production of life-saving medical solutions for aortic diseases.
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
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
ISO 13485ISO 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.
About the Company
Jotec
Industry
Healthcare
Description
Das Unternehmen stellt hochwertige Produkte und Lösungen zur Behandlung von Aortenerkrankungen her.
Not a perfect match?
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Full-timeOn-siteExperiencedGomaringen - MEDIRA GmbH
Produktionsmitarbeiter Nähen Implantat(m/w/x)
Full-timeOn-siteExperiencedBalingen - Gebrüder Frei GmbH & Co. KG
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Full-timeOn-siteExperiencedAlbstadt