QA Jobs in Fremont, CA

Performs quality assurance activities in a life sciences and clinical diagnostics environment, including document control, internal audits, audit reporting, batch record review, CAPA and nonconformance management, validation execution, SOP development, and quality metrics monitoring. The role supports regulatory inspections, management reviews, and materials and CAPA review boards while ensuring compliance with ISO 13485, ISO 14971, and FDA quality requirements.

Proofread and edit localized content for grammar, syntax, punctuation, consistency, and formatting issues. Translate occasional English content, test web applications and user interfaces on Mac OS X and iOS, document localization bugs, and verify fixes. Execute test cases, clearly communicate reproduction steps, prioritize issues, and collaborate independently or with diverse teams in a fast-paced environment, including occasional non-business hours, weekends, and holidays.

Supports quality assurance and regulatory compliance activities for medical device products. Responsibilities include maintaining Quality Management System activities, investigating nonconformances, supporting corrective and preventive actions, organizing quality documentation, contributing to continuous improvement, and assisting with audits and quality metrics. The intern collaborates with Manufacturing, Engineering, Regulatory Affairs, Supplier Quality, and Operations teams.

Supports quality assurance and regulatory processes for medical device products, including Quality Management System activities, nonconformance investigations, corrective and preventive actions, documentation review, audits, quality metrics, compliance, and continuous improvement. Collaborates with manufacturing, engineering, regulatory affairs, supplier quality, and operations teams while gaining hands-on experience in product and process quality.

Designs and executes test plans for print software tools, collaborates with field service engineers to reproduce and triage hardware-related bugs, manages software releases, and troubleshoots issues on printers. The role requires testing complex hardware, working effectively with software engineers, and supporting technical hardware users.

Design and implement test plans for desktop tools supporting 3D printing workflows. Reproduce and triage bugs with applications engineers, drive desktop software releases, and collaborate with DevOps and software engineering teams to automate testing. The role requires understanding CAD-like applications, desktop software testing or 3D printing, and working effectively with technical software users.

Provides quality assurance oversight for GxP facilities, utilities, equipment, analytical instruments, and computerized systems supporting biologic drug products. Coordinates change controls, deviations, CAPAs, investigations, validation activities, audits, quality metrics, inspection readiness, and data integrity programs. Partners with Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs to maintain compliance with US and international cGMP requirements and continuously improve quality systems.

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.

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.