Software Quality Engineer - Onsite (W2)

Select Source International

Pleasanton, CA, USA

Published: 6/14/2022

Technology

Full Time

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

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.