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Supplier Quality Auditor(m/w/x)
On-site auditing of quality management systems for medical device components at a healthcare manufacturer. Certified Lead Auditor status and ISO 13485 expertise preferred. Global travel up to 50%, 30 days annual leave.
Requirements
- Bachelor’s degree or equivalent industry experience
- Experience in quality-related auditing
- Certified Lead Auditor, ISO 13485 preferred
- Knowledge of industry standards and regulations
- Analytical and root-cause analysis skills
- Excellent English communication skills
- Ability to work independently
- Proficiency in Microsoft Office Suite
- Keen attention to detail
- High integrity and ethical standards
- Critical thinking and sound judgment
- Teamwork skills and adaptability
- Legal authorization to work without sponsorship
Tasks
- Evaluate supplier quality management systems and processes
- Audit documentation to ensure regulatory compliance
- Track non-conformances and corrective actions
- Assess new suppliers for suitability
- Reassess existing suppliers for ongoing compliance
- Monitor and ensure consistent supplier performance
- Collaborate with suppliers to implement CAPAs
- Verify the effectiveness of corrective actions
- Drive continuous improvement initiatives with suppliers
- Maintain complete and accurate audit documentation
- Prepare audit results for senior management
- Report performance metrics to senior management
- Work closely with internal stakeholders
- Support suppliers in meeting quality requirements
- Assist suppliers with regulatory compliance
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- ISO 9001
- ISO 17025
- ISO 22716
- FDA
- CFR
- EU MDR
- Microsoft Office Suite
- Quality management software
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Supplier Quality Auditor(m/w/x)
On-site auditing of quality management systems for medical device components at a healthcare manufacturer. Certified Lead Auditor status and ISO 13485 expertise preferred. Global travel up to 50%, 30 days annual leave.
Requirements
- Bachelor’s degree or equivalent industry experience
- Experience in quality-related auditing
- Certified Lead Auditor, ISO 13485 preferred
- Knowledge of industry standards and regulations
- Analytical and root-cause analysis skills
- Excellent English communication skills
- Ability to work independently
- Proficiency in Microsoft Office Suite
- Keen attention to detail
- High integrity and ethical standards
- Critical thinking and sound judgment
- Teamwork skills and adaptability
- Legal authorization to work without sponsorship
Tasks
- Evaluate supplier quality management systems and processes
- Audit documentation to ensure regulatory compliance
- Track non-conformances and corrective actions
- Assess new suppliers for suitability
- Reassess existing suppliers for ongoing compliance
- Monitor and ensure consistent supplier performance
- Collaborate with suppliers to implement CAPAs
- Verify the effectiveness of corrective actions
- Drive continuous improvement initiatives with suppliers
- Maintain complete and accurate audit documentation
- Prepare audit results for senior management
- Report performance metrics to senior management
- Work closely with internal stakeholders
- Support suppliers in meeting quality requirements
- Assist suppliers with regulatory compliance
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 13485
- ISO 9001
- ISO 17025
- ISO 22716
- FDA
- CFR
- EU MDR
- Microsoft Office Suite
- Quality management software
About the Company
Solventum
Industry
Healthcare
Description
Das Unternehmen ist ein junges Gesundheitsunternehmen, das innovative Lösungen an der Schnittstelle von Gesundheit, Material- und Datenwissenschaft entwickelt.
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