Quality Systems and Risk Management Manager

Keller Executive Search is partnering with a leading manufacturing organization to appoint an experienced Quality Systems and Risk Management Manager. This is a pivotal role for a quality professional who thrives at the intersection of systems governance, regulatory compliance, and proactive risk management, and who wants to make a measurable impact on product quality and operational excellence. Reporting into senior leadership, you will own the design, maintenance, and continuous improvement of the quality management system while leading a structured approach to risk identification, mitigation, and control across the product lifecycle. You will work cross-functionally with operations, engineering, supply chain, and external partners to ensure that quality standards, regulatory requirements, and customer expectations are consistently met. This is an excellent opportunity for someone ready to shape quality strategy, strengthen audit readiness, and embed a culture of continuous improvement. Our client values rigor, collaboration, and forward-thinking problem solving, and offers a stable, growth-oriented environment where quality leadership is genuinely valued. Key Responsibilities Own, maintain, and continuously improve the quality management system to ensure ongoing compliance with applicable standards and regulations Lead the organization's risk management program, including risk assessments, mitigation planning, and corrective and preventive actions (CAPA) Plan, conduct, and coordinate internal and external audits, and manage responses to regulatory and customer audits Develop, review, and control quality documentation, procedures, and records to support audit readiness Manage supplier and contract-manufacturer quality, including qualification, monitoring, and periodic on-site assessments Analyze quality data and trends to drive root-cause investigations and measurable improvements Partner with operations, engineering, and supply chain to embed quality and risk controls across the product lifecycle Lead, mentor, and develop quality staff and champion a culture of continuous improvement Prepare and present quality and risk metrics and reports to senior management Additional Information Location: United States; specific site details shared later in the process. Working pattern: primarily on-site with occasional remote flexibility based on business needs. Requirements Essential Bachelor's degree in engineering, quality, life sciences, or a related technical field 5+ years of experience in quality systems, quality assurance, or quality management within a manufacturing or regulated environment Working knowledge of ISO 13485, FDA Quality System requirements, and ISO 14971 risk management principles Practical knowledge of risk management methodologies and CAPA processes Experience planning and conducting internal and external audits Strong analytical, documentation, and problem-solving skills Ability to work on-site as the…