QA Team Lead (for Medical Laboratory)

Position Summary:

We are seeking a highly experienced and motivated QA Team Lead to oversee and manage all aspects of quality assurance and quality control within our comprehensive commercial laboratory in Ho Chi Minh City. This crucial role ensures compliance with ISO 15189:2022, Circular 2429/BYT-QLKH, and all relevant Vietnamese medical regulations. The QA Team Lead will manage internal and external quality assurance programs, and will be responsible for the quality of testing across all laboratory departments (hematology, biochemistry, immunology, microbiology, molecular diagnostics, pathology, and genetics).

Responsibilities:

• Develop, implement, and maintain a comprehensive quality management system (QMS) in accordance with ISO 15189:2022 and Circular 2429/BYT-QLKH.
• Oversee all aspects of internal quality control (IQC), including the development, implementation, and monitoring of IQC programs for all laboratory departments.
• Manage the external quality assessment (EQA) program, ensuring participation in relevant proficiency testing schemes and maintaining accreditation standards.
• Conduct regular internal audits to identify areas for improvement and ensure compliance with regulations and internal procedures.
• Manage the investigation and resolution of non-conformances and corrective actions, ensuring timely implementation of corrective and preventive actions (CAPA).
• Develop and deliver training programs for laboratory staff on quality assurance principles and procedures.
• Maintain comprehensive quality documentation, including SOPs, records, and reports.
• Liaise with regulatory bodies and external accreditation agencies.
• Develop and maintain a strong safety culture within the laboratory.
• Manage the QA team, assigning tasks, providing training, and mentoring team members.
• Participate in the development and implementation of new testing methods and technologies.
• Collaborate with laboratory managers and department heads to ensure quality across all aspects of laboratory operations.
• Continuously monitor and update the QMS to reflect changes in regulations and best practices.
• Prepare reports and present findings to management.

Job Requirements:

• Bachelor's degree in Medical Technology, Clinical Laboratory Science, or a related field.
• Minimum of 5 years of experience in a medical laboratory setting, with at least 3 years in a QA/QC role.
• Proven experience in implementing and maintaining ISO 15189:2022 compliant QMS in a clinical laboratory.
• In-depth knowledge of Vietnamese medical regulations, particularly Circular 2429/BYT-QLKH.
• Demonstrated experience in managing internal and external quality assurance programs.
• Strong understanding of various laboratory testing methodologies across multiple disciplines (hematology, biochemistry, immunology, microbiology, molecular diagnostics, pathology, and genetics).
• Excellent analytical, problem-solving, and decision-making skills.
• Strong leadership, communication, and interpersonal skills.
• Proficiency in Microsoft Office Suite and laboratory information systems (LIS).
• Fluency in Vietnamese and English (written and spoken).