Jobs at Sirtex Medical Limited

Lead administration and continuous improvement of the medical device Quality Management System (QMS) and eQMS. Drive CAPA, NCR, audit programs, management review, metrics, system validation, and cross-functional quality initiatives to ensure compliance with FDA QMSR, ISO 13485, MDSAP and other global regulations. Provide SME guidance, perform root-cause analysis, and support regulatory inspections and quality transformations.

Lead supplier qualification, audits, and ongoing management for medical device suppliers. Drive SCAR/CAPA, supplier validation, change control, KPIs, and continuous improvement while ensuring ISO 13485, FDA QMSR, and ISO 14971 compliance and supporting new product introductions and technology transfers.