Quality Engineer - QMS
Core
Manage the Asia Quality System, policies, and programs to ensure compliance with global standards and drive quality initiatives across the region.
Role type
Quality Management Representative / Quality Engineer
Builds
Quality management systems and processes for the Asia region
Domain
Manufacturing / Quality Assurance / Regulatory Compliance
Required skills
QMS documentation management, internal and external auditing, regulatory change monitoring, quality data analysis, cross-functional collaboration, customer complaint management, supplier complaint management, training delivery, risk assessment
Preferred skills
Quality Engineering certification, experience with ISO 9001/13485/GMP standards
Technologies
ISO 9001, ISO 13485, GMP, CCAR, SCAR, PPAP, QIR, Mastercontrol
Responsibilities
Develop and maintain QMS documentation for regulatory compliance; conduct internal audits and support external audits; analyze quality data to identify trends; manage customer and supplier complaint investigations; lead management reviews and report on QMS performance; train staff on quality procedures and tools; ensure local QMS aligns with global practices.
Seniority
Mid-level, hands-on IC