Job Responsibilities

1. Review and approve batch records before submission to the Document Control Center
2. Maintain and revise departmental quality documents and SOPs.
3. Conduct self-inspections and internal audits to ensure compliance with quality management system requirements.
4. Track and verify the effectiveness of corrective actions arising from audit findings and non-conformities.
5. Support and accompany external auditors during regulatory, customer, and certification audits.
6. Prepare CAPA reports and monitor implementation progress.
7. Coordinate and manage employee training programs and training records.
8. Perform routine audits and spot checks of workshop records and batch documentation.
9. Manage engineering change control processes from initiation through closure.
10. Continuously improve departmental quality systems and oversee compliance with quality procedures and requirements.
11. Perform any other duties assigned by the superior.

Job Requirement

1. Bachelor’s Degree in Quality Management, Engineering, Manufacturing, Industrial Management, or related discipline.
2. Familiarity with related ISO standard and/or GMP requirements
3. Experience in document review, document control, or quality management systems (QMS) will be an added advantage
4. Prior experience in the medical device industry is preferred.
5. Good communication, coordination, and interpersonal skills.
6. Detail-oriented, well-organized, and able to uphold quality and compliance standards.
7. Knowledge of CAPA and NCR processes.
8. Experience participating in external & internal audits.
9. Workshop management or on-site operational experience is an advantage.