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Introduction:

Ban Chang Subdistrict, Uthai District, Phra Nakhon Si Ayutthaya Province 13210

Responsibilities:

1. Supervise and manage QA/QC operations related to medical device manufacturing to ensure full compliance with applicable quality standards and regulatory requirements.
2. Implement, maintain, and improve Quality Management System (QMS) in accordance with ISO 13485, GMP, and relevant regulatory standards.
3. Lead and supervise QA/QC staff, including task assignment, performance monitoring, coaching, and on-the-job training.
4. Conduct in-process inspections, final product inspections, and quality audits to ensure products meet specifications and customer requirements.
5. Handle non-conformities, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement activities.
6. Prepare and review quality documentation such as SOPs, WI, inspection records, deviation reports, and quality reports.
7. Coordinate with Production, Engineering, and other related departments to resolve quality issues and improve process efficiency.
8. Support internal and external audits (customer audits, ISO audits, regulatory audits) and ensure timely corrective actions.
9. Communicate quality issues and performance reports to management effectively.

Requirements:

1. Bachelor’s degree in Engineering, Science, or a related field.
2. At least 5 years of experience in QA/QC within the medical device manufacturing industry.
3. Proven experience in supervising and managing subordinates in a QA/QC or quality-related function.
4. Strong knowledge of ISO 13485, GMP, and medical device quality standards.
5. Experience in quality tools such as CAPA, root cause analysis, and risk management.
6. Ability to communicate in basic to intermediate English, both written and spoken.
7. Strong leadership, problem-solving, and analytical skills.
8. Detail-oriented with a strong sense of responsibility and quality mindset.
9. Able to work effectively in a manufacturing environment and cross-functional teams.