AI-Enabled Quality Systems Tech for MedTech

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

Job summary

Johnson & Johnson’s DePuy Synthes division seeks a Tech Professional, Quality Systems, AI to support AI-enabled modernization of enterprise quality systems. You will ensure regulatory compliance (GxP, 21 CFR Part 11) while driving automation across complaint handling, CAPA, nonconformance, and document management.

Based in Raynham, MA, this role partners with Quality, Regulatory, Manufacturing, and Technology teams to deliver intelligent quality workflows and insightful dashboards.

Qualifications

• 6 years of progressive experience supporting enterprise quality systems.
• Hands-on experience with enterprise quality management systems.
• Working knowledge of GxP, 21 CFR Part 11, data integrity (ALCOA+).
• Demonstrated ability delivering automation or AI-enabled improvements.
• Strong SQL and data analysis skills for quality data.
• Experience with validated system changes, testing, and documentation.

Responsibilities

• Provides day-to-day technical support for enterprise quality systems.
• Supports and enhances quality platforms covering complaint handling, CAPA, nonconformance, and document control.
• Identifies and delivers AI and automation use cases across quality processes.
• Partners with Data Science and AI teams to define data requirements and validate models.
• Ensures AI solutions comply with 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.
• Collaborates with Quality process owners to configure enhancements and support UAT.

Skills

SQL

Data analysis

Python

AI/ML

Quality systems knowledge

Troubleshooting

Education

Bachelor's degree in Computer Science

Master's degree in Information Systems

Tools

Veeva Vault QMS

TrackWise

ETQ

SAP ERP

Job description

Johnson & Johnson’s DePuy Synthes division seeks a Tech Professional, Quality Systems, AI to support AI-enabled modernization of enterprise quality systems. You will ensure regulatory compliance (GxP, 21 CFR Part 11) while driving automation across complaint handling, CAPA, nonconformance, and document management.

Based in Raynham, MA, this role partners with Quality, Regulatory, Manufacturing, and Technology teams to deliver intelligent quality workflows and insightful dashboards.