Sr QMS Developer

Sr QMS Developer

Job Location:

Sunnyvale, CA

Duration:

1 Year

Shift Schedule:

Hybrid (3 days)

Summary:

This is a software engineering role focused on building applications and AI capabilities for our regulated quality systems landscape. The person will design and develop Java-based applications, services, and integrations that support GxP processes, and will design, build, and support Python-based AI agents that automate and augment those same processes. The emphasis of this role is engineering, not platform configuration. We are looking for a strong developer who can write production Java and Python, design solutions on AWS, and do so inside a validated environment. Familiarity with an enterprise QMS such as TrackWise is important context, but deep configuration expertise is not the primary requirement, the ability to build, integrate, and support software around it is.

Responsibilities:

• Design, develop, test, and deploy Java-based applications, microservices, and REST APIs supporting quality, compliance, and post-market processes.
• Build full-stack components Spring Boot services, data access layers, and front-end screens including user interfaces that present AI-generated recommendations to quality reviewers.
• Develop integrations and web services between the QMS platform and surrounding enterprise systems, including outbound/inbound web services and event-driven interfaces.
• Write and maintain unit, integration, and automated regression tests; participate in code review and manage source control, branching, and release processes.
• Troubleshoot and resolve production defects across application, integration, and database layers.
• Design, develop, deploy, and support LLM-based agents in Python that assist quality processes.
• Build and tune RAG pipelines, prompt templates, evaluation harnesses, and guardrails; measure agent accuracy, drift, and regression against defined acceptance criteria.
• Integrate agent outputs into quality workflows through APIs, including human-in-the-loop review, confidence thresholds, fallback behavior, and full capture of the audit trail.
• Take ownership of an existing AWS-hosted AI framework post-implementation, including production support, enhancement, and new agent development.
• Establish monitoring and observability for AI components, quality metrics, latency, token cost, and failure modes.
• Design and document AWS architecture for AI and application workloads Bedrock and/or SageMaker, Lambda, API Gateway, ECS, S3, IAM, and VPC-based network design.
• Partner with architecture review, security review, and infrastructure groups to get designs approved and deployed.
• Produce technical specifications, process flows, functional and technical design documentation.
• Perform solution design, requirements definition, testing, and validation support through implementation.
• Comply with regulatory, computer system validation, and change control requirements; produce the associated validation deliverables.
• Work with process owners to identify continuous improvement and automation opportunities, and recommend solutions using system standards and best practices.
• Work closely with onsite teams, offshore teams, vendor partners, managers, and executives to ensure the release of high-quality solutions.
• Support and train users on new and modified functionality, highlighting the impact on business processes.

Required Skills:

• Minimum 8 years of software engineering experience, with a majority delivering applications in regulated or otherwise highly controlled enterprise environments.
• Strong, current, hands-on core Java development Spring Boot, REST API design, multithreading, SQL, and relational data modeling.
• Full-stack capability, including a modern front-end framework such as React or Angular.
• Minimum 2 years building and shipping production AI/LLM solutions in Python agent frameworks (LangChain / LangGraph / Bedrock Agents / ClientP or equivalent), RAG, vector stores, prompt engineering, and systematic evaluation.
• Hands-on AWS architecture and deployment experience Bedrock or SageMaker, Lambda, API Gateway, S3, IAM, VPC networking; infrastructure-as-code (CloudFormation or Terraform) and CI/CD.
• Demonstrated experience developing or integrating with an enterprise Quality Management System (TrackWise, Veeva Vault QMS, MasterControl or similar) APIs, web services, data model, and workflow integration points.
• Experience in the medical device, pharmaceutical, or life sciences industry and systems regulations (21 CFR Part 11, GxP, GAMP 5, computer system validation).
• Experience working with business end users, gathering requirements, and producing detailed design specifications.
• Familiarity with Software Development Lifecycle (SDLC) processes; ability to work on multiple projects concurrently with minimum supervision.
• Good verbal and written communication skills.