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Medline

QSR Auditor

Medline

Posted

3 weeks ago

Greater Kuala Lumpur

Remote

MYR 6K

Mid Level

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Sema

Sema Summary

The QSR Auditor will conduct audits of Medline Asia suppliers to ensure compliance with internal and external regulations. This role requires strong analytical skills and the ability to communicate effectively with vendors.

About Company

Medline is the largest provider of medical-surgical products and supply chain solutions, serving all points of care globally. The company focuses on improving clinical, financial, and operational outcomes in healthcare.

Core Requirements

  • Bachelor’s Degree
  • Fluent in English
  • Knowledge of ISO 13485 and FDA regulations
  • Strong time management skills
  • Experience in quality management systems

Responsibilities

  • Audit suppliers per internal SOP and regulations.
  • Draft and publish high-quality audit reports.
  • Conduct CAPA follow-ups and evidence reviews.
  • Provide guidance to vendors on quality management.
  • Support pre-audit and 3rd party audit projects.
  • Address vendor questions and provide necessary training.
  • Complete other assignments related to quality management.

Must Have skills

ISO 13485 knowledgeFDA regulations understandingStrong reporting skillsGood communication skillsFamiliarity with office software

Job Keywords

QSRAuditorQuality ManagementISO StandardsFDA Compliance

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