Lead Software Engineer, Digital Quality & Compliance

Abbott seeks a Digital Quality and Compliance Lead for its Neuromodulation Division in Plano, Texas. This role drives digital transformation initiatives to enhance quality intelligence, regulatory compliance, and risk management across the product lifecycle through automation, analytics, and AI-enabled solutions.

Responsibilities

• Design and maintain automated workflows in QMS platforms; identify automation opportunities for CAPA, complaints, change control, and audit processes
• Support system validation activities and maintain compliance with FDA, EU MDR, ISO 13485, and data integrity requirements
• Develop dashboards and automated reporting tools to monitor quality metrics and support management reviews
• Lead digital transformation initiatives and cross-functional projects implementing quality and compliance solutions
• Collaborate with Quality, Regulatory Affairs, Operations, R&D, IT, and Cybersecurity teams to identify high-value improvement opportunities

Requirements

• Bachelor's degree in Engineering, Computer Science, Information Systems, Quality, or Life Sciences
• Experience with workflow automation, low-code/no-code platforms, or business process automation tools
• Strong analytical and problem-solving skills with excellent stakeholder communication
• 4+ years supporting Quality Systems in regulated industry (preferred)
• Knowledge of FDA 21 CFR Part 11, Part 820, EU MDR, ISO 13485, and Computer System Validation
• Experience with electronic QMS platforms such as Veeva, TrackWise, or ETQ Reliance (preferred)
• Medical device, diagnostic, biotechnology, or pharmaceutical industry experience (preferred)