Director, Quality Data Analytics

Essential Duties And Responsibilities

• Define and execute the enterprise Quality Data Analytics strategy aligned with enterprise priorities.
• Lead and develop a team of analytics professionals and project/program managers, ensuring strong capability development and succession planning.
• Establish standards for analytics, reporting, and data governance across Quality functions.
• Oversee analytics supporting, at minimum, CAPA, complaints, audits, nonconformances, supplier quality, post-market surveillance and other attributes and characteristics of our process and products that are Critical to Quality or associated with the Cost of Poor Quality.
• Ensure analytics outputs meet regulatory requirements (FDA QSR/QMSR, ISO 13485, EU MDR, and MDSAP, at minimum).
• Serve as a key leader during regulatory inspections, owning analytics narratives and data defensibility.
• Drive cross-functional collaboration across Quality, Regulatory, Manufacturing, and IT.
• Drive continuous improvement, automation, and adoption of advanced analytics techniques.
• Establish program management frameworks, governance, and reporting standards.
• Manage prioritization across multiple stakeholders and enterprise demands;
• Other duties as assigned.

Desired Minimum Qualifications

• Bachelor’s degree in Data Science, Engineering, Statistics, Quality, Computer Science, or related field.
• 12+ years of experience in data analytics or business intelligence.
• 7+ years of people leadership experience, including managing managers or large teams.
• Strong knowledge and expertise in Quality Management Systems and regulatory standards.
• Experience supporting regulatory inspections and audits.
• Experience in the medical device industry.
• Experience leading enterprise programs and portfolios.
• Proficiency in SQL and data visualization tools (e.g. Power BI, Tableau).
• Strong executive communication and stakeholder influence skills.
• Strong program/project management expertise.
• Ability to travel up to 25% if needed.