Lead, Digital Quality & Compliance

Thornton Tomasetti; Plano (TX); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefit

Global recognition

Job summary

Abbott in Plano, TX seeks a Lead of Digital Quality and Compliance in the Neuromodulation division to drive quality intelligence, regulatory insights, and risk management across the product lifecycle.

The role leads automation and analytics initiatives, collaborates with Quality, Regulatory Affairs, IT, and Operations to implement innovative digital solutions that improve patient safety and product quality.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, or related field.
• Experience with workflow automation, low-code/no-code platforms, or business process automation tools.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.

Responsibilities

• Quality Systems Automation: design, configure and maintain automated workflows in QMS and related systems; automate CAPA, complaints, nonconformances, change control, audits, training, supplier quality, and document control.
• Systems Administration and Compliance Support: validate computerized systems; maintain configurations, access controls, audit trails and electronic records; ensure FDA/EU MDR/ISO 13485 data integrity compliance.
• Data Analytics and Reporting: develop dashboards and automated reports; analyze quality trends; support management reviews with automated data collection.
• Continuous Improvement: lead digital transformation within Quality; optimize processes; apply Lean, Six Sigma and risk-based methods; evaluate AI and advanced analytics for quality applications.
• Project Management: lead system implementation and enhancement projects; develop plans, testing protocols, and deployment strategies; coordinate with vendors and cross-functional teams.

Skills

Workflow automation

Low-code/no-code

Analytical thinking

Communication & stakeholder mgmt

Education

Bachelor's degree in Engineering/CS/IS/Quality/Life Sciences

Master's degree (preferred)

Tools

Power Platform

Power Automate

Power BI

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Lead, Digital Quality and Compliance

Working at Abbott

You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plano, Texas location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. We are seeking a highly motivated and collaborative Digital Quality and Compliance Lead to drive digital transformation initiatives that improve quality intelligence, signal detection, regulatory intelligence, and proactive risk management across the product lifecycle. Individual contributor with comprehensive knowledge in automation and ability to execute highly complex or specialized projects. Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. This role will serve as the primary coordinator and business lead for a cross-functional transformation initiative focused on leveraging analytics, automation, AI-enabled insights, and external intelligence platforms to improve visibility into emerging quality, compliance, product performance, and patient safety risk. This role will work closely with Quality, Regulatory Affairs, Product Surveillance, Operations, R&D, IT, Privacy, and Cybersecurity teams to identify high-value opportunities, implement innovative solutions, and support adoption across the organization.

What You’ll Work On

• Quality Systems Automation
  Develop, configure, and maintain automated workflows within QMS platforms and related enterprise systems.
  Identify opportunities to automate quality processes including CAPA, complaints, nonconformances, change control, audits, training, supplier quality, and document control.
  Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
  Design system integrations between Quality, ERP, PLM, CRM, and Manufacturing Execution Systems (MES).
  Implement automation solutions that improve process consistency, compliance, and user experience.

• Systems Administration and Compliance Support
  validation activities for computerized systems in accordance with company procedures and regulatory requirements.
  Maintain system configurations, user access controls, audit trails, and electronic records.
  Ensure compliance with FDA, EU MDR, ISO 13485, and data integrity requirements.
  Assist in preparation for regulatory inspections and audits by supporting system documentation and evidence generation.

• Data Analytics and Reporting
  Develop dashboards and automated reporting tools to monitor quality metrics and KPIs.
  Analyze quality data trends and identify opportunities for process improvement.
  Support management review activities through automated data collection and reporting.

• Continuous Improvement
  Lead digital transformation initiatives within the Quality organization.
  Collaborate with stakeholders to optimize business processes and eliminate manual activities.
  Apply Lean, Six Sigma, and risk-based methodologies to improve quality system effectiveness.
  Evaluate emerging technologies including AI and advanced analytics for quality applications.

• Project Management
  Lead system implementation and enhancement projects.
  Develop project plans, requirements, testing protocols, and deployment strategies.
  May liaise with external vendors.
  Coordinate vendors, consultants, and cross-functional teams to ensure successful project execution.

Required Qualifications

• Bachelors degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, or a related field.
• Experience with workflow automation, low-code/no-code platforms, or business process automation tools.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.

Preferred Qualifications

• Masters degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, or a related field.
• 4+ years of experience supporting Quality Systems in a regulated industry.
• Experience with electronic QMS platforms such as Veeva, TrackWise, ETQ Reliance, or similar systems.
• Strong understanding of: FDA 21 CFR Part 820 21 CFR Part 11 EU MDR / IVDR ISO 13485 GAMP 5 Computer System Validation (CSV)
• Experience in medical devices, diagnostics, biotechnology, or pharmaceutical industries.
• Knowledge of Power Platform, Power Automate, Power BI or equivalent automation tools.
• Experience integrating QMS systems with ERP, PLM, or manufacturing systems.

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: NM Neuromodulation LOCATION: United States > Texas > Plano : 6901 Preston Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.