Sr. SQE - 外商

Key Responsibilities

• Coordinate product and QSD registration activities for medical devices
• Maintain product-related licenses and permits
• Organizes and manages the submission process of approved products such as line extension, change submission.
• Organizes and archives registration files, to ensure the accuracy and quality of the documentation
• Handling the report on product adverse incidents to authority
• Maintain the Quality Documentation based on the document control system.
• Ensure the compliance of QMS towards applicable medical devices regulations
• Ensure that all QMS are properly captured, reviewed, deployed, and documented.
• Support in creating, updating, and developing the training material for QMS.
• Support in managing the change request, subsequent steps till closure, and appropriate approval process in the Change Management system
• Support in planning and execution of both internal audits and external audits
• Review and archive Quality records, and maintain the archival list
• Consolidate yearly Quality Data Analysis from Process Owners as input for the Quality Management Review
• Ensure the training processes are implemented effectively in the organization and enhance the existing process to achieve optimal operational objectives.
• Manage administrative duties as well as ad-hoc projects assigned by the line manager

Key Requirements

• Knowledge of GMP/GDP regulations and concepts is preferred.
• Work experience in a quality function in a regulated environment (medical devices/pharmaceutical industry)
• In-depth know-how of QMS regulations: ISO 13485, applicable local regulations is preferred.
• Experience as lead/auditee in third party audits is preferred.