Quality Manager

The Quality Manager plays a key leadership role in overseeing the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485. As part of middle management, this role ensures quality compliance across all departments, manages quality processes and audits, and supports continuous improvement initiatives. The Quality Manager reports directly to the Quality Director and serves as a liaison between upper leadership and operations teams to ensure product quality, regulatory alignment, and process integrity.

Reports to:

Quality Director

• Lead and oversee the implementation and maintenance of the QMS in compliance with ISO 13485 standards.
• Supervise Quality Team personnel and ensure execution of inspection, documentation, and traceability procedures.
• Manage internal and external audits, including audit readiness, follow-ups, and corrective actions.
• Ensure document control systems, change management procedures, and training records are current and compliant.
• Oversee CAPA (Corrective and Preventive Action) processes and support root cause analysis for non-conformances.
• Collaborate with Production, Engineering, Supply Chain, and other departments to ensure quality is built into all operations.
• Track and report on key quality metrics and trends, including defect rates, audit findings, and customer complaints.
• Foster a culture of quality, compliance, and continuous improvement throughout the organization.

• Textile, physical science, business management, or related degree.
• Strong leadership, organizational, and communication skills.
• Ability to analyze data, identify risks, and implement effective solutions.
• Understanding of quality tools such as CAPA, risk management, root cause analysis, and document control.

• Experience with FDA, MDSAP, or CE regulatory frameworks.
• Proficiency with electronic QMS platforms or validation systems.
• Bilingual (English/Chinese) is a plus.