Senior QMS Developer

Our Client, an American Biotechnology company, is looking for a Senior QMS Developer for their Sunnyvale, CA/ Hybrid location.

Responsibilities:

• Application Development - GxP Systems
• 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
• AI Engineering
• 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 behaviour 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
• Architecture, Integration and Compliance
• 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

Requirements:

• 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 modelling
• 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 / MCP 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
• Hands-on TrackWise experience web services (OWS/IWS), data model, workflows, business rules and TWC automation
• Experience validating or qualifying AI/ML-enabled systems in a GxP context traceability, model documentation, human-in-the-loop controls, periodic performance review
• Experience with post-market surveillance and complaint handling processes
• Exposure to integration with SAP systems
• Reporting development experience (Crystal Reports, Quality View or equivalent)
• Should contribute to team building measures such as Knowledge Management and Mentoring

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities