Director Quality System and Regulatory Compliance

About the Role

The Director Quality System and Regulatory Compliance is responsible to support CQO with the implementation of strategies to develop, implement, and maintain the quality management system (QMS) across HOYA Vision Care entities (HVC), and improve the level of quality and regulatory compliance in HVC.

This position also owns the global inspection readiness program, oversees the global ISO13485 certification, and creates an effective oversight of HVC entities QMS performance (e.g. CAPA). This position owns Global Management review and prepares it in cooperation with site/regional Quality teams.

The Director Quality System and Regulatory Compliance, oversees market’s intelligence and provides proactive gap assessment on competitors field actions and recalls, audits/483 observations, warning letters and other market actions; ensure proactive correction of identified gaps in HVC entities. The Director Quality System and Regulatory Compliance wil...