Quality System Manager

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