AI-Enabled Quality Systems Engineer (MedTech)

Relha LLC; Raynham (MA); Hybrid; USD 94,000 - 170,000; Full time

Job summary

Johnson & Johnson, DePuy Synthes, is seeking a Tech Professional in Raynham, MA to advance AI-enabled quality systems across the enterprise. You will provide day-to-day technical support for validated quality platforms and drive AI/automation improvements in a regulated MedTech environment.

The role requires 6+ years in quality tech, strong SQL and data analysis skills, and experience with QMS tools like Veeva Vault QMS or TrackWise. Travel up to 20% may be needed.

Qualifications

• Requires 6+ years of progressive experience supporting enterprise quality systems or quality technology in a MedTech/manufacturing environment.
• Hands-on experience with enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise, ETQ, Sparta) covering complaint handling, CAPA, nonconformance, and document control.
• Strong knowledge of GxP, 21 CFR Part 11, CSV, and data integrity (ALCOA+) requirements.
• Experience identifying and delivering automation or AI-enabled improvements within quality processes.
• Proficiency in SQL and data analysis to profile and interpret quality data across systems.
• Experience supporting validated system changes through formal change control, testing, and documentation.
• Experience with troubleshooting, root-cause analysis, and cross-functional collaboration.
• Proficiency with Python or similar scripting for automation and data workflows.
• Familiarity with Power BI/Tableau for quality metrics and dashboards.
• Preferred: MedTech/medical device domain and ISO 13485, EU MDR, FDA QSR/QMSR familiarity.

Responsibilities

• Provides day-to-day technical support for enterprise quality systems, troubleshooting issues and escalating as needed.
• Supports and enhances quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, and document management.
• Identifies and delivers AI and automation use cases across quality processes, including triage and document summarization.
• Partners with Data Science and AI teams to define data requirements and validate model outputs within quality workflows.
• Ensures AI/automation solutions meet GxP, 21 CFR Part 11, and ALCOA+ with proper validation and human-in-the-loop controls.
• Analyzes quality system data to identify trends and bottlenecks, recommending improvements.
• Supports computer system validation activities, including requirements, test scripts, and traceability.
• Builds dashboards and reporting to provide Quality leadership with system performance visibility.
• Collaborates with Quality process owners to gather requirements and support UAT and releases.
• Assesses implications of technology changes (ERP/PLM migrations) and defines requirements ahead of cutover.

Skills

SQL & Data Analysis

AI & Automation

GxP Compliance

Quality Management Systems

Document Control

Change Control

Validation

Python

Power BI

Tableau

Education

Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related

Master’s degree in Information Systems, Data Science, or Engineering

Tools

Veeva Vault QMS

TrackWise

ETQ

Sparta

Job description

Johnson & Johnson, DePuy Synthes, is seeking a Tech Professional in Raynham, MA to advance AI-enabled quality systems across the enterprise. You will provide day-to-day technical support for validated quality platforms and drive AI/automation improvements in a regulated MedTech environment.

The role requires 6+ years in quality tech, strong SQL and data analysis skills, and experience with QMS tools like Veeva Vault QMS or TrackWise. Travel up to 20% may be needed.