Experience

Medical Devices

• Medical Equipment Manufacturing
• 400 - 500 Employee

• Quality Head (APAC)

  • May 2020 - Present

  • Promote, create and improve standards of quality within APAC; develop and implement Quality Strategy and provide strategic leadership. • Responsible for the regional QMS and its integrated programs within the respective region, such as QS training, internal, external and supplier audits, nonconformances, CAPAs, records management, FAs, SQM, procurement, servicing, distribution, and post market surveillance. • Set-up LOCs and in-country QMR aligned with local regulations or laws. • Maintains regulatory changes. • Manages on local distribution and warehouse management; local required establishment licenses, or QMS certifications. • Manages IEs processes; timely post-market surveillance & vigilance (Field Actions and Product Complaints) management. Show less



Medical Devices Industry

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regional Business Quality Manager (ASEAN)

  • Dec 2013 - May 2020

  • Lead and provides guidance to ASEAN countries including: Singapore / Malaysia / Indonesia / Thailand / Myanmar / Cambodia, on QS effective implementation and maintenance. • ASEAN LT / SMR for sites; LOCs set-up, site certification and support on PLC Management. • Manage 3PLs Operation and Service Providers including Distributors. • Responsible sites on all post auditing activities, drive execution of CAPAs, Audits. • Lead sites on Supplier Management, Non-Conformance / Escalation / Medical & AERM / FSCAs. • Track quality compliance metrics, initiatives for CIs and compliance enforcement. • Drive for complaint vigilance execution in the countries. Show less