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 global procedures are updated and revised to comply with regulatory and ISO requirements
• Drive the standardization of practices across the company through Quality Management System through collaboration with the Quality Heads of regions and entities
• Oversee QMS implementation and ensure compliance in HSO local sites
• Own the MasterControl platform
• Develop and maintain a training platform and associated content on quality and compliance, oversees compliance of training program in cooperation with HR department
• Support management of CAPA (including approval) as required
• Gather data required for the preparation of Global Management Review
• Lead and Support quality improvement projects/ initiatives
• Drive continual and preventive improvement of quality management systems through supporting the conformity of processes and product quality
• Manage and coordinate HOYA Corporation and external audits in the sites and provide support to external audits as required
• Participate in Internal (Site and Global) HSO audits as required
• Liaise with notified body for timely implementation of the audits, provide necessary documents as requested by the notified body
• Manage and develop team

Experience

• At least 5 years of experience in the management of product quality or quality systems in highly regulated industry (Pharma or Medical Device)
• Have managed external audits of Notified Bodies, & preferably FDA
• Have monitored product quality in production or in the field
• Familiar with Quality System Regulation, 21 CFR 820 regulation, ISO 13485, MDSAP and MDR requirement

Education

• Degree in Engineering or equivalent technical experience
• Formal education on Quality Management preferred

Skills

• Quality Orientation, Continuous improvement, technical and professional knowledge and skills in Quality Assurance, Quality System Management and Compliance
• Core Leadership skill: Adaptability, coach and develop others, drive execution, authenticity, collaborate, make decisions, resolve conflict, and influence
• Staffing skills, Strong Leadership and People skills
• Project Management skills (both written and oral)
• Excellent Communication and Presentation skills
• Able to lead and motivate cross-functional teams
• Budgeting skills
• Analytical skills that demonstrate the ability to recognize when system or staff adjustments are needed
• Trained and certified lead internal auditor as per ISO 9001, ISO13485
• Proficient in Microsoft office, Excel spreadsheet, process mapping, flowcharting, database systems
• Knowledge of Power BI is a plus

Work Location

• International Office environment

Travel Requirement

• Able to travel up to 25% of the time, mainly to US, Europe, Asia (include Japan, Thailand, China)

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes.