Quality System Manager

Main Purpose of Job

The Quality System Manager is responsible to develop, implement and sustain the Quality Management System (QMS) across HOYA Surgical Optics (HSO) entities and improve the level of regulatory compliance across the company. This role will embed a culture of continuous improvement throughout the company, and lead the team to achieve quality management system targets for customers and business goals.

Role and Responsibilities

• Lead the Quality System function to ensure quality system development and compliance with FDA Quality System Regulation, ISO13485, MDR and other regulatory / quality requirements
• Establish, implement, and maintain Quality Management System (QMS) across HSO entities
• Develop the Management Systems strategy, arrange key management milestones, and demonstrate solid progress against plan
• Implement all relevant procedures described in the Quality Management System (QMS)
• Ensure all globa...