Sr. QMS Developer - Hybrid (Sunnyvale, CA)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Sr. QMS Developer on a contract basis to support our Customer's business needs. This role is hybrid in Sunnyvale, CA.

Role Overview:

• 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
• 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

Qualifications:

• 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.
• 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.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.