Director QA OPS Americas

Director, QA Operations Americas provides strategic and operational leadership for Quality Assurance teams across the Americas, aligning regional quality activities with Sonova’s quality management system and applicable medical device regulations. Serves as the liaison between Global Quality and regional Operations to drive compliance, operational excellence, and continuous improvement while partnering with senior leaders and local quality teams. Responsibilities include leading and developing QA teams, coordinating with operations and regulatory affairs, ensuring compliance with ISO 13485, EU MDR, FDA 21 CFR Part 820, and MDSAP, maintaining inspection readiness and audits, overseeing CAPA/nonconformance/change control/document control, monitoring KPIs and root-cause analysis, driving cross-functional quality improvements, and fostering a culture of quality and accountability across the region. A strong background in regulated medical device quality, quality systems, Lean/Six Sigma or data analytics, and English proficiency is required; a Master’s degree and experience with SAP or digital quality tools are pluses.