{"schemaVersion":"jobsearcher.job.v1","id":"dcd55beee2b555405650138c","url":"https://jobsearcher.com/jobs/dcd55beee2b555405650138c","canonicalUrl":"https://jobsearcher.com/jobs/dcd55beee2b555405650138c","title":"Sr QMS Developer","description":"Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr QMS Developer.Job Description:Job Title: Sr QMS DeveloperJob Type: Contract Job Location: Sunnyvale, CAWork Schedule: OnsitePay Rate: $88, Based on experienceDescription: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.Roles and Responsibilities:Application Development — GxP SystemsDesign, develop, test and deploy Java-based applications, microservices and REST APIs supporting quality, compliance and post-market processesBuild full-stack components — Spring Boot services, data access layers and front-end screens — including user interfaces that present AI-generated recommendations to quality reviewersDevelop integrations and web services between the QMS platform and surrounding enterprise systems, including outbound/inbound web services and event-driven interfacesWrite and maintain unit, integration and automated regression tests; participate in code review and manage source control, branching and release processesTroubleshoot and resolve production defects across application, integration and database layersAI EngineeringDesign, 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 criteriaIntegrate agent outputs into quality workflows through APIs, including human-in-the-loop review, confidence thresholds, fallback behaviour and full capture of the audit trailTake ownership of an existing AWS hosted AI framework post-implementation, including production support, enhancement and new agent developmentEstablish monitoring and observability for AI components quality metrics, latency, token cost and failure modesArchitecture, Integration and ComplianceDesign and document AWS architecture for AI and application workloads Bedrock and/or SageMaker, Lambda, API Gateway, ECS, S3, IAM and VPC-based network designPartner with architecture review, security review and infrastructure groups to get designs approved and deployedProduce technical specifications, process flows, functional and technical design documentationPerform solution design, requirements definition, testing and validation support through implementationComply with regulatory, computer system validation and change control requirements; produce the associated validation deliverablesWork with process owners to identify continuous improvement and automation opportunities, and recommend solutions using system standards and best practicesWork closely with onsite teams, offshore teams, vendor partners, managers and executives to ensure the release of high quality solutionsSupport and train users on new and modified functionality, highlighting the impact on business processesSkill/Job Requirements:Minimum 8 years of software engineering experience, with a majority delivering applications in regulated or otherwise highly controlled enterprise environmentsStrong, current, hands-on core Java development — Spring Boot, REST API design, multithreading, SQL and relational data modellingFull-stack capability, including a modern front-end framework such as React or AngularMinimum 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 evaluationHands-on AWS architecture and deployment experience Bedrock or SageMaker, Lambda, API Gateway, S3, IAM, VPC networking; infrastructure-as-code (CloudFormation or Terraform) and CI/CDDemonstrated 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 pointsExperience 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 specificationsFamiliarity with Software Development Lifecycle (SDLC) processes; ability to work on multiple projects concurrently with minimum supervisionGood verbal and written communication skillsSkill/Job Requirements — Preferred:Hands-on TrackWise experience web services (OWS/IWS), data model, workflows, business rules and TWC automationExperience validating or qualifying AI/ML-enabled systems in a GxP context traceability, model documentation, human-in-the-loop controls, periodic performance reviewExperience with post-market surveillance and complaint handling processesExposure to integration with SAP systemsReporting development experience (Crystal Reports, Quality View or equivalent)Should contribute to team building measures such as Knowledge Management and MentoringTop 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 platformsGxP / 21 CFR Part 11 / GAMP 5 computer system validation experience .About Maxonic:Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.Interested in Applying? Please apply with your most current resume. Feel free to contact Nishit Giri (nishit.g@maxonic.com/(408) 400-2329) for more details.","company":"Maxonic","rawCompany":"maxonic","city":"Sunnyvale","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-09-25T09:13:53.962Z","occupations":[{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"}],"industries":[{"code":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"},{"code":"513210","title":"Software Publishers","slug":"software-publishers"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr QMS Developer","description":"Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr QMS Developer.Job Description:Job Title: Sr QMS DeveloperJob Type: Contract Job Location: Sunnyvale, CAWork Schedule: OnsitePay Rate: $88, Based on experienceDescription: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.Roles and Responsibilities:Application Development — GxP SystemsDesign, develop, test and deploy Java-based applications, microservices and REST APIs supporting quality, compliance and post-market processesBuild full-stack components — Spring Boot services, data access layers and front-end screens — including user interfaces that present AI-generated recommendations to quality reviewersDevelop integrations and web services between the QMS platform and surrounding enterprise systems, including outbound/inbound web services and event-driven interfacesWrite and maintain unit, integration and automated regression tests; participate in code review and manage source control, branching and release processesTroubleshoot and resolve production defects across application, integration and database layersAI EngineeringDesign, 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 criteriaIntegrate agent outputs into quality workflows through APIs, including human-in-the-loop review, confidence thresholds, fallback behaviour and full capture of the audit trailTake ownership of an existing AWS hosted AI framework post-implementation, including production support, enhancement and new agent developmentEstablish monitoring and observability for AI components quality metrics, latency, token cost and failure modesArchitecture, Integration and ComplianceDesign and document AWS architecture for AI and application workloads Bedrock and/or SageMaker, Lambda, API Gateway, ECS, S3, IAM and VPC-based network designPartner with architecture review, security review and infrastructure groups to get designs approved and deployedProduce technical specifications, process flows, functional and technical design documentationPerform solution design, requirements definition, testing and validation support through implementationComply with regulatory, computer system validation and change control requirements; produce the associated validation deliverablesWork with process owners to identify continuous improvement and automation opportunities, and recommend solutions using system standards and best practicesWork closely with onsite teams, offshore teams, vendor partners, managers and executives to ensure the release of high quality solutionsSupport and train users on new and modified functionality, highlighting the impact on business processesSkill/Job Requirements:Minimum 8 years of software engineering experience, with a majority delivering applications in regulated or otherwise highly controlled enterprise environmentsStrong, current, hands-on core Java development — Spring Boot, REST API design, multithreading, SQL and relational data modellingFull-stack capability, including a modern front-end framework such as React or AngularMinimum 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 evaluationHands-on AWS architecture and deployment experience Bedrock or SageMaker, Lambda, API Gateway, S3, IAM, VPC networking; infrastructure-as-code (CloudFormation or Terraform) and CI/CDDemonstrated 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 pointsExperience 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 specificationsFamiliarity with Software Development Lifecycle (SDLC) processes; ability to work on multiple projects concurrently with minimum supervisionGood verbal and written communication skillsSkill/Job Requirements — Preferred:Hands-on TrackWise experience web services (OWS/IWS), data model, workflows, business rules and TWC automationExperience validating or qualifying AI/ML-enabled systems in a GxP context traceability, model documentation, human-in-the-loop controls, periodic performance reviewExperience with post-market surveillance and complaint handling processesExposure to integration with SAP systemsReporting development experience (Crystal Reports, Quality View or equivalent)Should contribute to team building measures such as Knowledge Management and MentoringTop 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 platformsGxP / 21 CFR Part 11 / GAMP 5 computer system validation experience .About Maxonic:Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.Interested in Applying? Please apply with your most current resume. Feel free to contact Nishit Giri (nishit.g@maxonic.com/(408) 400-2329) for more details.","datePosted":"2026-09-25T09:13:53.962Z","dateModified":"2026-09-25T09:13:53.962Z","hiringOrganization":{"@type":"Organization","name":"Maxonic","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sunnyvale","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"dcd55beee2b555405650138c"},"url":"https://jobsearcher.com/jobs/dcd55beee2b555405650138c"}}