Deputy Quality Manager

Mô tả Công việc
Job Purpose
The Deputy Quality Manager is responsible for supporting the Quality Manager in establishing, maintaining, and improving the Quality Management System (QMS) in compliance with GMP and relevant ISO standards. The role focuses on ensuring cleanroom production quality, regulatory compliance, and continuous improvement during the expansion of medical device manufacturing.
Quality Management & Compliance
Assist in managing and maintaining the Quality Management System in compliance with GMP and ISO standards (ISO 13485 / ISO 13484 as applicable).
Ensure all production activities meet regulatory and internal quality requirements for medical devices.
Participate in preparing, implementing, and updating SOPs, quality manuals, and related documentation.
Cleanroom Management
Oversee and manage ISO Class 8 cleanroom operations in accordance with GMP requirements.
Ensure cleanroom standards (environmental monitoring, hygiene, contamination control) are strictly followed.
Supervise validation, qualification, and routine monitoring of cleanroom facilities and equipment.
Audit & Inspection Support
Support internal audits, external audits, and inspections by regulatory authorities and certification bodies.
Prepare audit reports, manage corrective and preventive actions (CAPA), and ensure timely closure of non-conformities.
Training & Supervision
Provide GMP, ISO, and cleanroom compliance training to production and quality staff.
Support the Quality Manager in supervising quality personnel and coordinating cross-functional activities.