QA Jobs in Fremont, CA

Lead quality engineering for medical device manufacturing: support NPI and sustainment, implement risk-based quality systems, perform FMEAs, develop/execute verification/validation and IQ/OQ/PQ/PV, address deviations and drive CAPAs to ensure compliance with ISO 13485 and 21 CFR 820.

The Robotics Software QA/Test Engineer will ensure software quality through testing practices, monitor test robots, triage issues, and improve testing tools.

Lead and scale the QA organization and GxP compliance for bioprinted tissue therapeutics. Establish a phase-appropriate GMP QMS, oversee Document Control, CAPA, deviations, inspection readiness, regulatory interactions (FDA/EMA/Health Canada), QA oversight of GMP cell manufacturing, support QC and data integrity, and author/review quality sections for regulatory submissions.

Own the full QA lifecycle for AI-powered legal solutions: design and run unit, integration, system, performance, and scalability tests; integrate automated suites into Azure DevOps CI/CD; generate and evaluate AI-assisted test cases; maintain defect tracking and quality metrics; collaborate with security and engineering teams to ensure production-ready releases.

Own and build automated test suites and UAT for APIs and customer-facing apps. Validate REST and gRPC services, automate browser workflows, perform exploratory and release testing, triage defects, embed quality in CI/CD, and pioneer AI-assisted testing practices.

Design, build, and maintain automated test frameworks and scripts. Lead test strategy, planning, and execution across functional, load, integration, security, server-side, and ETL testing. Create test artifacts, run automated tests, analyze results, report defects, participate in CI/CD, code reviews, and agile ceremonies, and drive issue resolution.

Lead implementation and maintenance of the ISO 13485:2016 Quality Management System for medical device projects. Own design assurance, risk management, DHF, V&V, document control, internal audits, management review, and eQMS/CSV activities. Develop SOPs, train staff, support regulatory submissions (510(k)/PMA), and ensure audit readiness while collaborating with project teams across hardware, software, and AI/ML workstreams.