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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
Key Responsibilities:
Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)Lead and support external inspections and regulatory auditsPlan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actionsIdentify areas of non-compliance and drive continuous improvement initiativesAct as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closureMaintain and continuously improve site CAPA processes and systemsDevelop, track, and report CAPA metrics to support management review activitiesSupport corrective and preventive action processes across the siteCollaborate cross-functionally to standardize quality system policies and proceduresProvide training and g...