Sr. Quality Management System Software Developer

Maxonic Inc.; Sunnyvale (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Maxonic Inc. is seeking a senior software engineer to design and build Java-based applications and Python AI agents within a validated environment. You will create REST services, integrate with QMS platforms, and develop and maintain AI-driven solutions on AWS.

The role focuses on engineering rather than platform configuration, requiring strong Java and Python production coding, experience with AWS Bedrock/SageMaker, and familiarity with TrackWise or similar QMS integrations.

Qualifications

• 8+ years of software engineering in regulated or highly controlled environments.
• Strong Java development with Spring Boot, REST APIs, SQL.
• Production AI/LLM experience in Python and agent frameworks.

Responsibilities

• Design, develop, test and deploy Java-based apps and REST APIs for quality and post-market processes.
• Build full-stack components including UI for AI-generated recommendations.
• Develop integrations between QMS and enterprise systems via web services.
• Write tests and manage source control, CI/CD and releases.
• Troubleshoot production defects across apps, integrations and databases.
• Develop LLM-based Python agents for quality processes and guardrails.
• Tune RAG pipelines, prompts, evaluation, and monitoring for accuracy.
• Integrate AI outputs into workflows with human-in-the-loop and audit trails.
• Own AWS-hosted AI framework post-implementation and support.
• Establish observability for AI metrics, latency, and costs.

Skills

Java development

Python AI engineering

AWS architecture

GxP compliance

QMS integration

CI/CD

TrackWise integration

SDLC

Front-end development

LLM/NLP

Tools

LangChain

Bedrock/SageMaker

Terraform

CloudFormation

Job description

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

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
• 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

Required Skills

• Strong core Java and full-stack application development in validated GxP environments (Spring Boot, REST APIs, SQL, modern front-end framework).
• Python-based AI engineering — LLM application and agent development (RAG, prompt engineering, orchestration, evaluation).
• AWS solution architecture for AI and application workloads (Bedrock/SageMaker, Lambda, API Gateway, ECS, S3, IAM, VPC).
• Systems integration and API/web service development against enterprise QMS platforms.
• GxP / 21 CFR Part 11 / GAMP 5 computer system validation experience.

Required

• 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

Preferred 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