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Software Quality Engineer

GForce Life Sciences

Software Quality Engineer

Software Quality Engineer 12-month Contract Onsite in Pleasanton, CA Must be able to work on a W2 Responsibilities

Support software verification and validation (VV) activities, including test protocols, plans, and reports.

Conduct non-product software assessments.

Collaborate on product cybersecurity assessments with cross-functional teams.

Review software and system documentation to ensure quality and compliance.

Maintain requirements traceability throughout the development lifecycle.

Support SDLC processes and perform risk assessments, FMEA, hazard analysis, and issue resolution.

Participate in sustaining engineering activities, including post-release support and issue resolution.

Support design reviews and represent Quality in approval processes.

Assist with post-release changes, audits, and quality system improvements.

Collaborate with cross-functional teams to ensure adherence to FDA, ISO 13485, IEC 62304 standards.

Qualifications

Bachelor's degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.

Minimum of 2 years' experience in software quality validation, systems engineering, or a related discipline.

Experience working in regulated industries such as medical devices, diagnostics, or pharmaceutical sectors.

Ability to work independently with self-motivation.

Strong analytical, communication, and teamwork skills.

Experience working in an audit setting is a plus.

Experience supporting product cybersecurity assessments is a plus.

Vacancy posted 4 days ago
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