AI-Driven Quality Systems Engineer

Johnson & Johnson MedTech; Raynham (MA); On-site; USD 94,000 - 170,000; Full time

Benefits offered by this job

Travel up to 20% domestic

Job summary

DePuy Synthes is recruiting a Tech Professional, Quality Systems, AI to support and modernize our enterprise quality platforms in a regulated MedTech environment. You will provide day-to-day technical support, drive AI-enabled improvements, and ensure compliance with GxP and 21 CFR Part 11.

The role partners with Quality, Regulatory, Manufacturing, and Technology teams, builds dashboards and reports, and identifies automation opportunities to reduce manual effort and accelerate cycle times

Qualifications

• Bachelor's degree is required.
• Master's degree is preferred.
• 6+ years of experience with enterprise quality systems in a regulated environment.
• Experience with validated quality platforms (CAPA, DOC control, audit).
• Strong SQL and data analysis skills; ability to derive insights from quality data.

Responsibilities

• Provides day-to-day technical support for enterprise quality systems.
• Supports and enhances quality platforms for complaint handling, CAPA, nonconformance, and document management.
• Identifies and delivers AI/automation opportunities across quality processes.
• Partners with Data Science/AI teams to define data requirements and validate model outputs.
• Ensures GxP, 21 CFR Part 11, and ALCOA+ data integrity in solutions.
• Builds dashboards and reports for Quality leadership.
• Supports system validation activities and change control.
• Collaborates with Quality, Regulatory, Manufacturing, and Technology teams.

Skills

Quality systems

SQL data analysis

Automation AI

Problem solving

Cross-functional

Education

Bachelor's degree in CS IS Engineering Life Sciences Quality

Master's degree in IS Data Science or Engineering

Tools

Veeva Vault QMS

TrackWise

ETQ

Sparta

Python

Power BI

Job description

DePuy Synthes is recruiting a Tech Professional, Quality Systems, AI to support and modernize our enterprise quality platforms in a regulated MedTech environment. You will provide day-to-day technical support, drive AI-enabled improvements, and ensure compliance with GxP and 21 CFR Part 11.

The role partners with Quality, Regulatory, Manufacturing, and Technology teams, builds dashboards and reports, and identifies automation opportunities to reduce manual effort and accelerate cycle times