Sr QMS Developer

Java / Spring Boot Full-Stack Development (Expert), Python AI / LLM Engineering (Advanced), AWS Architecture & Cloud Development (Advanced), QMS Systems Integration & APIs (Advanced), GxP / 21 CFR Part 11 / GAMP 5 Validation (Expert)

W2 Only

12+ Months

Sunnyvale, CA (Hybrid - 3 Days Onsite)

$80 - $85 on W2

We are seeking a highly experienced Sr QMS Developer to build and support software applications and AI capabilities within a regulated Quality Management Systems environment. This is primarily an engineering role rather than a QMS platform configuration role, requiring strong hands-on development experience in Java, Python, AWS, enterprise integrations, and AI/LLM technologies. The ideal candidate will have experience developing production applications in GxP-regulated environments, building Python-based LLM agents and RAG solutions, designing AWS architectures, and integrating enterprise QMS platforms such as Track Wise, Veeva Vault QMS, or Master Control.

Strong understanding of 21 CFR Part 11, GAMP 5, computer system validation, and change control is required.

• Design, develop, test, and deploy Java/Spring Boot applications, microservices, REST APIs, data access layers, and full-stack components supporting quality, compliance, and post-market processes.
• Build and support Python-based AI/LLM agents, including RAG pipelines, prompt engineering, agent orchestration, evaluation frameworks, guardrails, and human-in-the-loop workflows.
• Design and implement AWS solutions for application and AI workloads using services such as Bedrock/Sage Maker, Lambda, API Gateway, ECS, S3, IAM, and VPC.
• Develop and maintain integrations between enterprise QMS platforms and surrounding systems using APIs, web services, event-driven interfaces, and data integrations.
• Troubleshoot application, integration, database, and production issues while managing testing, code reviews, source control, CI/CD, and release processes.
• Support regulated SDLC and validation activities by producing technical documentation, design specifications, validation deliverables, audit trails, and change-control documentation.

• 8+ years of software engineering experience with strong hands-on Java, Spring Boot, REST APIs, SQL, multithreading, and relational data modeling.
• Full-stack development experience using a modern frontend framework such as React or Angular.
• 2+ years of production experience building AI/LLM solutions in Python, including agent frameworks, RAG, vector stores, prompt engineering, and systematic evaluation.
• Strong hands-on AWS architecture and deployment experience with Bedrock/Sage Maker, Lambda, API Gateway, S3, IAM, VPC, IaC, and CI/CD.
• Experience with enterprise QMS integration and regulated environments, including Track Wise, Veeva Vault QMS, Master Control, or similar platforms, with knowledge of GxP, 21 CFR Part 11, GAMP 5, and computer system validation.

• Hands-on Track Wise experience, including OWS/IWS, data model, workflows, business rules, and TWC automation.
• Experience validating AI/ML-enabled systems in a GxP environment, including traceability, model documentation, human-in-the-loop controls, and performance monitoring.
• Experience with post-market surveillance and complaint handling processes.
• Experience integrating SAP systems with QMS or other enterprise applications.
• Reporting development experience using Crystal Reports, Quality View, or equivalent tools.

• Strong understanding of regulated software development and computer system validation throughout the SDLC.
• Experience gathering requirements from business users and producing detailed functional and technical design specifications.
• Ability to manage multiple projects concurrently with minimal supervision in a highly controlled enterprise environment.
• Excellent communication skills with the ability to work effectively with onsite/offshore teams, vendors, business users, managers, and executives.
• Experience contributing to knowledge management, mentoring, and team development initiatives.