Not looking for candidates that are heavy in software/testing engineer skills. Need someone with more quality and process improvement experience.

This position works out of our Pleasanton, CA location. This is an ONSITE position. 

Possibility for conversion to permanent.

What you’ll do:

• Support software verification & validation (V&V) activities (test protocols, plans, reports), including non-product software assessment.
• Support product cybersecurity assessments in collaboration with cross-functional teams.
• Review software and system documentation to ensure quality and compliance.
• Maintain requirements traceability and support SDLC processes.
• Perform risk assessments (FMEA, hazard analysis) and drive issue resolution.
• Participate in sustaining engineering activities, including post-release support and issue resolution, may participate in design reviews and represent Quality in approvals.
• Support post-release changes, audits, and quality system improvements.
• Collaborate cross-functionally to ensure compliance with FDA, ISO 13485, IEC 62304.

Education and Experience:

• Minimum Bachelor’s degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.
• Minimum 2 years of experience in software quality, validation, systems engineering, or a related discipline.
• Experience working in a regulated industry (medical device, diagnostics, pharmaceutical).
• Self-motivated with the ability to work independently with minimal supervision. Strong analytical, communication, and teamwork skills.
• Experience in audit setting preferred.