Hybrid Supplier Quality Auditor

Posted 4 hours ago

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About the role

  • Supplier Quality Auditor responsible for assessing supplier compliance and quality standards at Solventum. Ensure delivery of better healthcare products and collaboration with innovative teams.

Responsibilities

  • Conduct Supplier Audits: Evaluate quality management systems, processes, and documentation to ensure regulatory compliance, and track non-conformances and corrective actions
  • Supplier Qualification and Assessment: Assess new suppliers for suitability and regularly reassess existing suppliers to ensure ongoing compliance and consistent performance
  • Issue Resolution & Continuous Improvement: Collaborate closely with suppliers to implement and verify the effectiveness of CAPAs and drive continuous improvement initiatives
  • Documentation & Reporting: Maintain complete audit documentation and prepare audit results and performance metrics for senior management
  • Cross-functional Collaboration & Communication: Work closely with internal stakeholders and support suppliers in meeting quality and regulatory requirements.

Requirements

  • Bachelor’s degree from accredited college or university or equivalent industry experience
  • Fundamental experience in a quality-related auditing role in a regulated industry
  • Certified Lead Auditor from an accredited agency (AAMI, ASQ, ISO, etc.), ISO 13485 preferred
  • In-depth knowledge of industry standards and regulations (Ex: ISO 13485, ISO 9001, ISO 17025, ISO 22716, FDA, CFR, EU MDR)
  • Strong analytical, root-cause analysis, and problem-solving skills
  • Excellent English written and verbal communication skills
  • Ability to work independently and manage multiple projects simultaneously
  • Proficiency in Microsoft Office Suite and quality management software
  • Keen attention to detail, with the ability to identify small issues that could escalate into larger problems if left unaddressed
  • Must demonstrate a high level of integrity, professionalism, and adherence to ethical standards in their conduct
  • Critical thinking skills are essential, enabling the candidate to make sound judgments
  • Strong team player, capable of working effectively with others, and possess the adaptability to handle changing priorities and work environments.

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

Job title

Supplier Quality Auditor

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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