QA Jobs in Fremont, CA

Leads localization testing engagements from scope estimation and environment setup through tester training, test execution, defect management, reporting, and sign-off. Coordinates with translation teams, engineers, project managers, testers, and clients to investigate and resolve defects, prevent duplicates, monitor progress, maintain testing equipment, and deliver quality results. Evaluates tester performance and supports the ongoing maturity of testing programs.

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.

Proofread and edit localized content for grammar, punctuation, consistency and cultural correctness; sometimes translate English to native language; execute test cases, identify and report localization/UI bugs, verify fixes, and test web/mobile applications.

Proofread and edit localized content for grammar, syntax, punctuation and consistency; sometimes translate from English; execute test cases on web and UI, log localization bugs, verify fixes, and communicate reproduction steps. Work on Mac/iOS devices and collaborate with diverse teams in a fast-paced, onsite environment.

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.

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.