Ban Chang Subdistrict, Uthai District, Phra Nakhon Si Ayutthaya Province 13210
Responsibilities:
- Supervise and manage QA/QC operations related to medical device manufacturing to ensure full compliance with applicable quality standards and regulatory requirements.
- Implement, maintain, and improve Quality Management System (QMS) in accordance with ISO 13485, GMP, and relevant regulatory standards.
- Lead and supervise QA/QC staff, including task assignment, performance monitoring, coaching, and on-the-job training.
- Conduct in-process inspections, final product inspections, and quality audits to ensure products meet specifications and customer requirements.
- Handle non-conformities, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement activities.
- Prepare and review quality documentation such as SOPs, WI, inspection records, deviation reports, and quality reports.
- Coordinate with Production, Engineering, and other related departments to resolve quality issues and improve process efficiency.
- Support internal and external audits (customer audits, ISO audits, regulatory audits) and ensure timely corrective actions.
- Communicate quality issues and performance reports to management effectively.
Requirements:
- Bachelor's degree in Engineering, Science, or a related field.
- At least 5 years of experience in QA/QC within the medical device manufacturing industry.
- Proven experience in supervising and managing subordinates in a QA/QC or quality-related function.
- Strong knowledge of ISO 13485, GMP, and medical device quality standards.
- Experience in quality tools such as CAPA, root cause analysis, and risk management.
- Ability to communicate in basic to intermediate English, both written and spoken.
- Strong leadership, problem-solving, and analytical skills.
- Detail-oriented with a strong sense of responsibility and quality mindset.
- Able to work effectively in a manufacturing environment and cross-functional teams.
