Automation-Driven Quality Systems Leader

Regulatory Jobs; Plano (TX); Vor Ort; USD 87.000 - 173.000; Vollzeit

Zusammenfassung

Abbott in Plano, TX is seeking a Lead for Quality Systems & Digital Transformation to drive automation, analytics, and regulatory intelligence across the product lifecycle. You will coordinate cross-functional teams and deploy AI-enabled insights to enhance patient safety and product performance.

The role requires strong experience in quality systems, cross-functional collaboration, and a solid foundation in regulatory requirements (FDA/ISO).

Qualifikationen

• Bachelor's degree in a related field and regulatory/quality systems exposure.
• Experience with workflow automation and low-code/no-code tools.
• Strong analytical and problem-solving capabilities.
• Excellent communication and stakeholder management skills.

Aufgaben

• Lead Quality Systems automation initiatives across QMS and enterprise systems.
• Design and implement integrations between Quality, ERP, PLM, CRM and MES.
• Develop dashboards and automated reports for quality metrics and KPIs.
• Support validation activities and maintain audit trails and CSV compliance.
• Drive continuous improvement using Lean, Six Sigma, and advanced analytics.

Kenntnisse

Workflow automation

Low-code/no-code

Analytical thinking

Stakeholder management

Ausbildung

Bachelor's degree in Engineering/Computer Science/Information Systems or Life Sciences

Master's degree preferred

Tools

Veeva

TrackWise

ETQ Reliance

Power Platform

Jobbeschreibung

Abbott in Plano, TX is seeking a Lead for Quality Systems & Digital Transformation to drive automation, analytics, and regulatory intelligence across the product lifecycle. You will coordinate cross-functional teams and deploy AI-enabled insights to enhance patient safety and product performance.

The role requires strong experience in quality systems, cross-functional collaboration, and a solid foundation in regulatory requirements (FDA/ISO).