Director, Quality Data Analytics

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Director, Quality Program Management, Quality Data Analytics provides enterprise leadership for Quality Analytics strategy, program execution, and data-driven transformation initiatives across the organization. This role is responsible for establishing and scaling advanced analytics capabilities while leading complex, cross-functional programs that enable proactive Quality Compliance, regulatory readiness, and enterprise risk management across the medical device lifecycle. The Director, Quality Program Management, Quality Data Analytics leads managers and/or advanced individual contributors and partners with senior leadership to embed data‑driven decision‑making across the organization.

• Define and execute the enterprise Quality Data Analytics strategy aligned with enterprise priorities.
• Lead and develop a team of analytics professionals and project/program manager, 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; and, Other duties as assigned.
• Additional duties, may include:
  Supporting development and execution of the Program Management strategy.
• Additional duties, may include:
  Leading a portfolio of strategic Quality programs and projects.

• 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.

$ - $ USD

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs:

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards |…