Director, Quality Data Analytics

Role: Director of Quality Program Management, specializing in Quality Data Analytics, leading enterprise-wide analytics strategy, program execution, and data-driven transformation initiatives within the medical device industry. Responsibilities: develop and oversee analytics supporting CAPA, complaints, audits, nonconformances, and post-market surveillance; establish standards for reporting, data governance, and regulatory compliance (FDA QSR, ISO 13485, EU MDR, MDSAP); lead cross-functional collaborations across Quality, Regulatory, Manufacturing, and IT; support regulatory inspections with analytics narratives; drive automation and advanced analytics adoption; manage teams of analytics professionals and project managers. Requirements: Bachelor's in Data Science, Engineering, Statistics, or related field; 12+ years in data analytics/business intelligence; 7+ years in leadership managing large teams; expertise in Quality Management Systems, regulatory standards, and medical device industry experience; proficiency in SQL, Power BI, Tableau; strong stakeholder influence skills; ability to travel up to 25%. High-Value: enterprise analytics in medical devices, regulatory compliance, cross-functional leadership, advanced data analytics, quality management, post-market surveillance, and experience supporting regulatory audits.