概要

• 給与

  80,000 THB ~ 120,000 THB

• 業界

  Manufacturing(Other)

• 仕事内容

  - Leads the regional QA team, responsible for the management of all regional quality related processes to support distribution, supply chain activities, vigilance, post market surveillance and operations at the distribution centers in the region.
  - Responsible for budgeting, resource management, hiring, people management, QMS management, compliance and inspection readiness, management of internal and external audits, and cross functional communication & collaboration.
  - Establishes, implements, and maintains a Quality Management System to meet the requirements of ISO 13485 standards.
  - Identifies areas for improvement for regional QA processes and/or work practices and leads projects in collaboration with the department heads with other QA heads of regions/sites.
  - Acts as lead auditor for Internal and External audits.
  - Responsible for the design, approval and communication of APAC annual audit program
  - Supports business in solving quality-related issues involving customers and distributors in the region.
  - Supervises, monitors and instructs distributors in the region regarding compliance to product related regulatory requirements, post-market surveillance processes and Good Distribution Practice.
  - Oversees and ensures that distributors, freight forwarders, and logistics vendors working for the Quality Agreements.
  - Responsible for QA oversight of 4PL vendor, including processes related to inbound, storage, inventory control, shipment, returns, etc.
  - Primary liaison for complaints and product quality related issues in all the countries in the region
  - Responsible for vigilance and adverse event reporting.
  - Ensures that reportable adverse events and the post-market surveillance activities comply with local regulatory requirements.
  - Supports the business in solving issues with customers and distributors that relate to quality.
  - Manages regional Non-conformances and CAPAs in an effective and timely manner.
  - Trains in the region on applicable regulations and quality requirements.
  - Participates in the design, development, and maintenance of quality KPIs and dashboards, in collaboration with the global team.
  - Supports global quality initiatives, projects and process improvements.