Digital Quality & Compliance Lead - QA Automation

Regulatory Jobs; Plano (TX); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Health insurance

High employer contribution retirement

Tuition reimbursement

FreeU education benefit

Great place to work

Job summary

Abbott in Plano, TX seeks a Lead, Digital Quality and Compliance to drive digital transformation across quality, regulatory intelligence, and patient safety risk management. You will lead automation efforts, analytics, and cross-functional collaboration with Quality, Regulatory Affairs, IT, and Operations.

The role focuses on implementing AI-enabled insights, monitoring quality metrics, and enhancing compliance across the product lifecycle in a regulated medical device environment.

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

• Automate quality processes within QMS platforms and related systems (CAPA, complaints, nonconformances, change control, audits, training, supplier quality, document control).
• Validate computerized systems per procedures and regulatory requirements; maintain configurations and audit trails.
• Develop dashboards and automated reports to monitor quality metrics and KPIs; analyze trends for improvements.
• Lead digital transformation initiatives within the Quality organization and collaborate to optimize processes.
• Oversee system implementation projects and coordinate cross-functional teams and external vendors.

Skills

Bachelor's degree required

Workflow automation

Analytical thinking

Communication skills

Education

Master's degree preferred

Tools

Power Platform/Power BI/Power Automate

Job description

Abbott in Plano, TX seeks a Lead, Digital Quality and Compliance to drive digital transformation across quality, regulatory intelligence, and patient safety risk management. You will lead automation efforts, analytics, and cross-functional collaboration with Quality, Regulatory Affairs, IT, and Operations.

The role focuses on implementing AI-enabled insights, monitoring quality metrics, and enhancing compliance across the product lifecycle in a regulated medical device environment.