Vacancy Description
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.
How You’ll Make an Impact:
Quality Assurance Related Activities
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 Corre...
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