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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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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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