Senior QMS Engineer — AI, Cloud & Java

Akraya, Inc.; Sunnyvale (CA); Hybrid; USD 110,000 - 117,000; Full time

Job summary

Akraya, Inc. is seeking a Sr QMS Developer to design, build, and support software in a regulated Quality Management Systems environment.

You will apply Java/Spring Boot, Python AI/LLM, and AWS expertise to deliver production-grade applications and AI capabilities in a GxP context. You will integrate enterprise QMS platforms such as TrackWise, Veeva Vault QMS, or MasterControl, ensure compliance with 21 CFR Part 11 and GAMP 5, and contribute to validation deliverables, change control, and audit

Qualifications

• 8+ years of software engineering in Java/Spring Boot and REST APIs.
• Experience building Python AI/LLM solutions and RAG pipelines.
• Hands-on AWS architecture including Bedrock/SageMaker, Lambda, API Gateway.
• Experience integrating TrackWise, Veeva Vault QMS, MasterControl.
• Knowledge of 21 CFR Part 11, GAMP 5, and computer system validation.

Responsibilities

• Design, develop, test, and deploy Java/Spring Boot apps and microservices.
• Build Python-based AI/LLM agents, including RAG pipelines.
• Design AWS solutions for application and AI workloads.
• Develop integrations with enterprise QMS platforms via APIs.
• Support regulated SDLC and validation activities with documentation.
• Troubleshoot issues and manage CI/CD and releases.

Skills

Java / Spring Boot

Python AI/LLM

AWS Architecture

QMS Integration

GxP 21 CFR Part 11

Tools

TrackWise

Veeva Vault QMS

MasterControl

Job description

Akraya, Inc. is seeking a Sr QMS Developer to design, build, and support software in a regulated Quality Management Systems environment.

You will apply Java/Spring Boot, Python AI/LLM, and AWS expertise to deliver production-grade applications and AI capabilities in a GxP context. You will integrate enterprise QMS platforms such as TrackWise, Veeva Vault QMS, or MasterControl, ensure compliance with 21 CFR Part 11 and GAMP 5, and contribute to validation deliverables, change control, and audit