Director, Quality Data Analytics

Director-level position leading enterprise Quality Data Analytics strategy and execution across medical device operations. Responsible for building advanced analytics capabilities, managing cross-functional programs, and driving data-driven decision-making aligned with regulatory compliance and organizational priorities.

Responsibilities

• Define and execute enterprise Quality Data Analytics strategy aligned with organizational priorities
• Lead and develop team of analytics professionals and program managers with succession planning focus
• Establish analytics standards, governance, and reporting frameworks across Quality functions
• Oversee analytics for CAPA, complaints, audits, nonconformances, supplier quality, and post-market surveillance
• Serve as key leader during regulatory inspections, managing analytics narratives and data defensibility

Requirements

• Bachelor's degree in Data Science, Engineering, Statistics, Quality, or related field
• 12+ years experience in data analytics or business intelligence
• 7+ years people leadership experience managing managers or large teams
• Strong knowledge of Quality Management Systems and regulatory standards (FDA QSR/QMSR, ISO 13485, EU MDR, MDSAP)
• Medical device industry experience with regulatory inspection and audit support
• Proficiency in SQL and data visualization tools (Power BI, Tableau, or equivalent)
• Enterprise program leadership and portfolio management expertise

Compensation: $166,750 - $228,850 USD base salary