JOB DETAILS

JOB DETAIL

- Make sure the Quality Management System (QMS) is followed at all times.
- Manage and control quality documents to meet company rules and external standards.
- Review and approve Device History Records (DHR) and product certificates for materials and semi-finished products.
- Support all types of audits (internal, customer, regulatory, and notified body) and ensure the site is always audit-ready.
- Approve product batch release to customers on behalf of the Quality Manager.
- Prepare, update, and maintain quality documents in both paper and electronic formats.
- Ensure compliance with Thai FDA requirements for manufacturing, import, and GMP license renewals.
- Review new regulatory updates and assess their impact on current processes.
- Prepare management review reports, monthly reports, and quality objective reports.
- Lead, coach, and train the document control team to maintain high work standards.

REQUIRED WORK EXPERIENCE

- Bachelor’s degree or higher in Science, Engineering, or a related field.
- 3–5 years of experience in Quality Assurance and Regulatory Affairs in the medical device or pharmaceutical industry.
- Good knowledge of Thai FDA regulations, ISO 13485, and GMP.
- Strong skills in analysis, documentation, and communication.
- Self-driven, detail-oriented, and able to lead a team.
- Good English communication skills.