Director Quality System And Regulatory Compliance

The Director Quality System and Regulatory Compliance is responsible to support CQOwith the implementation of strategies to develop, implement, and maintain thequality management system (QMS) across HOYA Vision Care entities (HVC), andimprove the level of quality and regulatory compliance in HVC. This position also owns the global inspection readiness program, oversees the globalISO13485 certification, and creates an effective oversight of HVC entities QMSperformance (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 will be a certified independent auditor (with registration in IRCA) and will be supporting Hoya Corporation audits program of other Hoya divisions. Duties and Responsibilities Develop, implement, and maintain the QMS across HVC entities Oversee and ensure compliance of all quality systems elements such as but not limited to documentation, trainings, CAPAs, management review, internal audits, change controls etc to regulatory requirements and quality standards Define QMS architecture for implementation across HVCsites Define requirements to QMS documents across HVC sites Drive implementation of One Global Management system in HVC, developGlobal procedures for key processes Define strategy for Global policy and Global Procedures Support the CQO in the implementation of strategies to monitor andimprove the level of regulatory compliance in HVC Ensure compliance tovariour regulatory requirements and create an effective oversight of other HVCentities Prepare HVC sites for theauthorities audits and support these audits as requried Develop and …