Quality Systems & Digital Transformation Lead

Hardware FYI; Plano (TX); Presencial; USD 87.000 - 173.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development

Health coverage

Retirement plan

Tuition reimbursement

Diversity recognition

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Workflow automation

Low-code/no-code

Analytical thinking

Communication

Stakeholder management

Educación

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

Master's degree (preferred)

Herramientas

Veeva

TrackWise

ETQ Reliance

Power Platform

Power Automate

Power BI

Descripción del empleo

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.