Director, Quality Data Analytics

Posted 18 Days Ago
Be an Early Applicant
8 Locations
In-Office
167K-229K Annually
Expert/Leader
Healthtech • Manufacturing
The Role
Lead enterprise Quality Data Analytics strategy and programs for medical devices. Build and manage analytics teams, establish governance and reporting standards, ensure regulatory-ready analytics (FDA, ISO, EU MDR), support inspections, drive cross-functional collaboration, automation, and advanced analytics to enable proactive quality compliance, risk management, and program delivery across CAPA, complaints, audits, supplier quality, and post-market surveillance.
Summary Generated by Built In

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.

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES
To 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 QUALIFICATIONS
The 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 training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your 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 LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo

Skills Required

  • 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 (FDA QSR/QMSR, ISO 13485, EU MDR, MDSAP).
  • Experience supporting regulatory inspections and audits.
  • Experience in the medical device industry.
  • Experience leading enterprise programs and portfolios.
  • Proficiency in SQL.
  • Proficiency in data visualization tools (Power BI, Tableau).
  • Strong executive communication and stakeholder influence skills.
  • Strong program/project management expertise.
  • Ability to travel up to 25% if needed.
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The Company
HQ: Princeton, New Jersey
3,489 Employees

What We Do

Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative technology product portfolio to include surgical instruments, neurosurgical products and advanced wound care products, through global acquisitions and development of new and innovative products and technologies to address unmet patient needs and improve outcomes. Integra is a global leader in neurosurgery and offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Our regenerative tissue technologies include products that address soft tissue, nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. The company has offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas. Integra products are ubiquitous in many hospital intensive care units and operating rooms around the world. Some of our high quality leading brands include AmnioExcel®, Bactiseal®, CerebroFlo®, CereLink® Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, Gentrix®, ICP Express®, Integra®, MatriStem® UBM, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, NeuraGen® 3D, PriMatrix®, SurgiMend®, TCC-EZ® and VersaTru® and are available through a combination of directly employed sales representatives, distributors and wholesalers

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