Software Quality Engineer - Onsite (W2)

Job Description

Job Description

Job Title: Software Quality Engineer (On W2)

Location: Pleasanton, CA 94588 – Onsite

Duration: 12 months contract with possibility of extension

Shift/Schedule: 8:00 AM - 5:00 PM/M-F

Experience with Medical Device Testing.

Job Description:

• 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.

\nCompany Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.\r\n\r\nAs a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.