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Medical Device Quality Specialist

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Medline Industries, LP Full time
Job Summary

We are seeking a highly skilled Medical Device Quality Specialist to join our team at Medline Industries, LP.

  • This role will involve managing quality performance of assigned suppliers, ensuring their compliance with our quality metrics and requirements.
  • The successful candidate will work closely with internal and external customers to ensure the supplier quality meets our standards.
  • In addition, this role will participate in activities to develop and improve supplier quality systems, product quality, and manufacturing processes.

Key Responsibilities:

  • Manage a portfolio of suppliers and act as the primary point of contact between suppliers and Corporate QA and Shanghai Office QA.
  • Monitor suppliers' maintenance of QMS through regular audits, focusing on P&PC and quality control.
  • Support and drive suppliers to build their own master process validation plans and monitor execution progress.
  • Coordinate and manage non-conformities with all related stakeholders and suppliers.
  • Direct and collaborate with supplier representatives on quality issues, ensuring timely corrective action implementation and contributing to supplier quality improvement programs.

Requirements:

  • 3+ years' experience in supplier quality management with sound improvement knowledge, working in the medical device industry is a plus.
  • Good communication skills, both English and Mandarin.
  • Team Spirit, Integrity, self-motivated, and ready to work under pressure.
  • Proven learning and adaptation capability.