Director of Quality Analytics & Regulatory Programs

Integra LifeSciences Corporation

Cordova (TN)

On-site

USD 167,000 - 229,000

Full time

2 days ago
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Job summary

Integra LifeSciences Corporation seeks a Director of Quality Data Analytics to lead enterprise analytics strategy and cross‑functional programs for Quality, Regulatory, Manufacturing, and IT. You will scale advanced analytics capabilities and drive data‑driven decision making across the organization.

The role requires 12+ years in data analytics with 7+ years leading teams, plus deep knowledge of Quality Management Systems and regulatory standards. Travel up to 25% is expected.

Qualifications

  • 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.

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 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.
  • Leading a portfolio of strategic Quality programs and projects.

Skills

Data analytics
Executive communication
Program management
Quality management systems
Regulatory knowledge
Travel up to 25%

Education

Bachelor’s degree in Data Science, Engineering, Statistics, Quality, Computer Science, or related field

Tools

SQL
Power BI
Tableau

Job description

Integra LifeSciences Corporation seeks a Director of Quality Data Analytics to lead enterprise analytics strategy and cross‑functional programs for Quality, Regulatory, Manufacturing, and IT. You will scale advanced analytics capabilities and drive data‑driven decision making across the organization.

The role requires 12+ years in data analytics with 7+ years leading teams, plus deep knowledge of Quality Management Systems and regulatory standards. Travel up to 25% is expected.

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