(Senior) Quality Specialist

Responsibilities

·Implements and supports ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.

·Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, China GSP & GMP.

·Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.

·Establish local and regional relationships with regulatory affairs, commercial, and logistics team.

·Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).

·Mainta...