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 assoc...