Job Description

Key Responsibilities

  • Regulatory Compliance & Oversight: Ensure the company adheres to MFDS regulations and manage QA operations related to post-market activities, including product labeling, importation requirements, and QMS maintenance.
  • Maintain ISO Certification: Oversee the continued compliance and maintenance of company’s ISO certification.
  • Audit Leadership: Serve as the primary point of contact during Corporate Quality Audits and external inspections, ensuring successful audit outcomes and compliance.
  • Quality Assurance Activities: Lead and collaborate with cross-functional teams to conduct internal audits, supplier audits, CAPA (Corrective and Preventive Actions), customer surveys, product validation, Quality Management Review meetings, and supplier performance management. Ensure that the most up-to-date quality documentation is utilized, and all quality records are properly maintained.
  • 3PL Oversight: Supervi...

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