· Manage and enforce in-house Quality Management System according to ISO13485 / MDD / MDR/ MDSAP requirements
· Review constantly the effectiveness and relevancy of SOPs, Quality Manual and Technical File
· Report to management team on the performance of the Quality Management System and Quality Improvement Plan
· Work closely with Regulatory Affairs function to develop and manage international product registrations
· Support Clinical, Design Development, Marketing, Business Development and Revenue functions upon request
· Support any non-compliance with respective outsourced third-party service providers and suppliers
· Lead daily operations and incidents arising from manufacturing and quality
· Support the submission of significant change notification and documentation to Notified Body
· Lead periodic key suppliers’ audit and suppliers’ evaluation
· Ensure validity of all suppliers’ certification and agreement
· Keep abreast, identify changes required to meet new standards in an ever-changing regulatory environment
· Manage entire manufacturing process from purchasing to final product release to ensure adequate inventory to fulfil customers’ order
· Take lead roles in ongoing design change and process validation
· Support external and internal audits
· Validate, monitor and measure to ensure related quality KPIs are achieved
