Senior Quality Specialist

Job description

Description The Senior Quality Specialist supports quality systems leading Corrective and Prevention Action (“CAPA”) co-ordination and execution, conducting internal audits under the direction of the Quality Systems Manager, and assembly of management review metrics. Acting as a backup to the Quality Systems Manager, this role executes quality system changes and supports external audit preparations. Essential Duties and Responsibilities: - CAPA Support : Plan and perform CAPA investigations, including root cause analysis, corrective and preventive actions, and disposition decisions. Ensure timely closure of CAPAs and maintain compliance with internal procedures and regulatory requirements. Work closely with Supplier Quality, Operations, Engineering, and Regulatory teams to drive resolution. - Internal Audits : Act as Lead Internal Auditor for ISO 13485: 2016, TGA and FDA regulation audits. Assist other internal auditors with audit processing, tracking, and CAPA (QRE) assignments. - Quality Metrics and Reporting : Prepare, analyze, and develop quality related Key Process Indicator (KPI) reports for Management Review meetings. Ensure KPIs accurately reflect trends, risks, and opportu...