AI Quality Systems Engineer - MedTech

Antler; Raynham (MA); On-site; USD 94,000 - 170,000; Full time

Job summary

Johnson & Johnson is recruiting for a Tech Professional, Quality Systems, AI, in Raynham, MA (and other locations) to modernize enterprise quality systems with AI capabilities. You will support, validate, and optimize quality platforms across complaint handling, CAPA, and document control.

Collaborating with Quality, Regulatory, Manufacturing and Technology teams, you will identify AI opportunities, ensure ALCOA+ data integrity, and drive improvements in cycle times while maintaining strict

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field.
• Master's degree in Information Systems, Data Science, or Engineering preferred.

Responsibilities

• Provides day-to-day technical support for enterprise quality systems, resolving issues with users.
• Supports and enhances validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, document management, training records, and audit management.
• Identifies and delivers AI and automation use cases across quality processes.
• Partners with Data Science and AI teams to define data requirements and validate model outputs.
• Ensures AI/automation solutions meet GxP, 21 CFR Part 11, and ALCOA+ data integrity.
• Analyzes quality system data to identify trends and improvement opportunities.
• Supports computer system validation activities including requirements, tests, and change control.
• Builds reporting, dashboards, and metrics for Quality leadership.

Skills

SQL & data analysis

Troubleshooting

Communication

Automation/AI

Documentation & validation

Education

Bachelor's degree in Computer Science or related

Master's degree preferred

Tools

Veeva Vault QMS

TrackWise

ETQ

Sparta

Python

Power BI

Job description

Johnson & Johnson is recruiting for a Tech Professional, Quality Systems, AI, in Raynham, MA (and other locations) to modernize enterprise quality systems with AI capabilities. You will support, validate, and optimize quality platforms across complaint handling, CAPA, and document control.

Collaborating with Quality, Regulatory, Manufacturing and Technology teams, you will identify AI opportunities, ensure ALCOA+ data integrity, and drive improvements in cycle times while maintaining strict