Senior Manager, Quality Data Analytics

Responsibilities

• Lead and develop a team of managers and/or senior analytics professionals, ensuring strong capability development and succession planning.
• Define and execute the Quality Data Analytics strategy and roadmap aligned with enterprise priorities.
• Establish standards for analytics, reporting, and data governance across Quality functions.
• Oversee analytics supporting CAPA, complaints, audits, nonconformances, supplier quality, and post‑market surveillance.
• Ensure analytics outputs meet regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP).
• Serve as a key leader during regulatory inspections, owning analytics narratives and data defensibility.
• Partner cross‑functionally with Quality, Regulatory, Manufacturing, and IT leaders.
• Drive continuous improvement, automation, and adoption of advanced analytics techniques.
• Manage prioritization across multiple stakeholders and enterprise demands; and, Other duties as assigned.

• Bachelor’s degree in Data Science, Engineering, Statistics, Quality, Computer Science, or related field
• 10+ years of experience in data analytics or business intelligence
• 5+ years of people leadership experience, including managing managers or large teams
• Strong expertise in Quality Management Systems (CAPA, complaints, audits, risk management, PMS/PMCF)
• Experience supporting regulatory inspections and audits
• Experience in the medical device industry
• Proficiency in SQL and data visualization tools (Power BI, Tableau)
• Strong executive communication and stakeholder influence skills
• Ability to travel up to 25% if needed.