Lead, Quality Systems & Digital Transformation
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Benefits offered by this job
Job summary
Abbott, a global healthcare leader, seeks a Lead, Quality Systems & Digital Transformation in Plano, TX. The role drives automation, data analytics, and regulatory intelligence across the product lifecycle, collaborating with Quality, Regulatory Affairs, and IT to elevate patient safety and compliance.
As an individual contributor, you will design programs for systematic monitoring, leverage AI-enabled insights, and advance cross-functional transformation initiatives within Neuromodulation.
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.
- Master's degree preferred.
- 4+ years of experience supporting Quality Systems in a regulated industry.
- Experience with electronic QMS platforms such as Veeva, TrackWise, ETQ Reliance, or similar.
- Knowledge of FDA 21 CFR Part 820, 21 CFR Part 11, EU MDR/IVDR, ISO 13485, GAMP 5, CSV.
- Experience in medical devices/biotech/pharma; Power Platform knowledge; integration with ERP/PLM/MES.
Responsibilities
- Quality Systems Automation: develop, configure, and maintain automated workflows within QMS platforms.
- Automate quality processes including CAPA, complaints, nonconformances, change control, audits, training, supplier quality, and document control.
- Design system integrations between Quality, ERP, PLM, CRM, and MES.
- Implement automation solutions to improve consistency, compliance, and user experience.
- Systems Administration and Compliance: support validation activities for computerized systems; maintain configurations, access controls, audit trails, and electronic records.
- Ensure compliance with FDA, EU MDR, ISO 13485, and data integrity requirements.
- Data Analytics and Reporting: develop dashboards and automated reporting tools; analyze quality data trends.
- Continuous Improvement: lead digital transformation within Quality; apply Lean, Six Sigma, risk-based methodologies.
- Project Management: lead system implementation, develop plans, testing protocols, deployment strategies; coordinate vendors.
Skills
Education
Tools
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.
Job Title Lead, Quality Systems & Digital Transformation
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. 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 Quality Systems & Digital Transformation 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.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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.
Operations Quality
NM Neuromodulation
United States > Texas > Plano : 6901 Preston Road
Standard
Yes, 5 % of the Time
Not Applicable
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
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