Quality Sys Spec I (Fixed Term - 6 months)

The Quality System Specialist (Fixed Term) supports the Quality Management System (QMS) implementation and maintenance in alignment with ISO 9001:2015 , SS620:2016 , ISO 13485 , and GDPMDS requirements. This role is pivotal in ensuring regulatory compliance, audit readiness, and continuous improvement within the Singapore Distribution Centre (SG DC). A significant portion (50%) of the role is dedicated to In Vitro Diagnostic Regulation (IVDR) -related activities, especially in labelling, traceability, document control, and audit support.

• Maintain and improve the QMS to meet applicable regulatory standards and business objectives.
• Support internal audits by preparing relevant documentation and ensuring process adherence.
• Identify nonconformances (NCs) , perform root cause analysis, issue Co...