SUMMARYThe 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.
ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform the following:
- 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.
DESIRED MINIMUM QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill and/or ability required for this position.
- 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.
Salary Pay Range:
$166,750.00 - $228,850.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
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, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
Integra - Employer Branding from Integra LifeSciences on Vimeo
