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SOSolventum

Supplier Quality Auditor(m/w/x)

Düsseldorf
Full-timeWith Home OfficeExperienced

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

EnglishBusiness Fluent

Tools & Technologies

ISO 13485ISO 9001ISO 17025ISO 22716FDACFREU MDRMicrosoft Office SuiteQuality management software
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