Job Details

A company is looking for a Director, Quality Systems & Compliance.Key ResponsibilitiesLead the design, implementation, and continuous improvement of a unified, enterprise-wide Quality Management System (QMS)Develop and oversee the annual internal audit program and manage external audits/inspectionsEstablish and report enterprise-level quality metrics and KPIs to support data-driven decision-makingRequired QualificationsBachelor's degree in Engineering, Life Sciences, or a related field10+ years of quality and compliance experience in the medical device industryDeep understanding of FDA QSR, ISO 13485, MDSAP, EU MDR, and related global regulationsProven success in leading internal and external audit programsExperience in implementing or optimizing electronic Quality Management Systems (eQMS)