Job Description

Your Job

  • Responsible for implementing, improving, and maintaining the effectiveness of the PMTH Quality Management System, including ISO 9001, ISO 13485, FDA, UL/CSA, and other relevant standards.
  • Responsible for the control and maintenance of PMTH documentation and records, including MyQMS.
  • Responsible for preparing and reporting quality performance metrics such as TCOQ, COPQ, QNs, and CAPAs.

    • Our Team

    You will be reporting to Quality Systems & Regulatory Manager

    What You Will Do

  • Implement and maintain the effectiveness of Quality Assurance systems to ensure full compliance with QMS standards and local requirements, including ISO 9001, ISO 13485, and FDA regulations when need
  • Ensure that all SOPs are established, updated, and aligned with global MPS documents, while meeting business and local regulatory needs.
  • Monitor PMTH manufacturing activities, post market information, and chang...

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