Digital Quality & Compliance Transformation Lead

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 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.