Manager, Quality Systems & Change Management

The Manager, Quality Systems & Change Management is responsible for the development, governance, effectiveness, and continuous improvement of the Quality Management System (QMS) and associated Change Management processes. This role serves as the organizational owner of the management system and is responsible for ensuring business processes remain effective, scalable, risk-based, compliant, and aligned with organizational objectives. The Manager provides leadership for Quality Systems and Change Management activities, including management system governance, complaint management, return material evaluation, investigations, corrective and preventive actions, risk management, configuration management, product data governance, and change implementation. Working cross-functionally with Engineering, Manufacturing, Regulatory Affairs, Compliance, Product Line Management, Supply Chain, Customer Care, and other business functions, this role ensures the management system enables quality, compliance, operational effectiveness, and business growth without creating unnecessary complexity or administrative burden. Success in this position requires strong systems thinking, leadership, technical judgment, business acumen, and a commitment to developing both people and organizational capability. **Essential Responsibilities** **Quality Management System Leadership** - Own and continuously improve the Quality Management System and associated governance processes. - Ensure management system processes remain effective, scalable, compliant, risk-based, and aligned with business objectives. - Monitor management system performance through quality metrics, process performance indicators, management reviews, audit outcomes, customer feedback, and improvement activities. - Assess management system effectiveness and identify opportunities to improve process capability, efficiency, consistency, and organizational performance. - Drive simplification, standardization, and optimization of business processes while maintaining appropriate controls. - Ensure appropriate integration and interaction between management system processes across the organization. - Support development and maintenance of procedures, work instructions, standards, and process documentation. **Investigation, Complaint & CAPA Management** - Provide leadership and oversight for complaint handling, return material evaluation, investigations, root cause analysis, corrective action, preventive action, and effectiveness verification processes. - Ensure quality issues are appropriately evaluated, investigated, resolved, and prevented from recurring. - Serve as the escalation resource for complex complaints, investigations, product issues, process issues, and systemic quality concerns. - Lead or support investigations requiring advanced technical judgment and cross-functional coordination. - Facilitate effective root cause analysis and evidence-based problem solving. - Ensure corrective and preventive actions address true systemic causes and drive sustainable improvement. - Promote organizational learning through effective investigation and knowledge-sharing practices. **Change Management & Configuration Governance** - Provide leadership and oversight for configuration management, product data governance, and change implementation activities. - Ensure product, process, documentation, training, ERP, software, and business system changes are appropriately assessed, coordinated, implemented, and verified. - Establish and maintain effective change management processes that balance control, compliance, and business agility. - Support successful execution of engineering, manufacturing, quality system, regulatory, and business process changes. - Ensure organizational adherence to established change management and configuration control requirements. - Promote consistency, discipline, and accountability in change execution across the enterprise. **Risk Management & Process Governance** - Promote adopti…