Senior/Lead Software Quality Engineer

OverviewSenior/Lead Software Quality Engineer to join one of our Leading Healthcare clients. The role focuses on software quality activities, regulatory compliance, and collaboration across product development and manufacturing teams.Location6101 Stoneridge Dr, Pleasanton, CA 94588, USADuration: 12 Months | 100% OnsitePay Range: $55/hr to $57/hr (On W2)ResponsibilitiesDevelop and deliver training on software development and validation.Create, execute, and oversee software validation protocols.Collaborate with engineering teams on system/software requirements, verification, and validation.Implement and manage code control, defect tracking, and risk analysis.Conduct audits (including Part 11) and support continuous improvement initiatives.Ensure compliance with FDA, ISO, QMS, and related regulatory standards.Required QualificationsBachelor’s degree in Engineering/Technical field or equivalent experience.5+ years of Software Quality Engineering experience.Knowledge of FDA, GMP, IEEE 1012, IEC 62304, ISO 13485.Strong skills in validation, risk controls, traceability, data analysis, and reporting.Prior medical device experience required.Preferred QualificationsASQ CSQE certification.Experience in large enterprise/cross-division environments.Strong communication, organizational, and multitasking skills.Ability to adapt in fast-paced, regulated environments.EligibilityWe are looking for candidates who are eligible to work with any employer without sponsorship.How to applyIf you’re interested, please click “Apply”.Job detailsSeniority level: Mid-Senior levelEmployment type: ContractJob function: Engineering and Information TechnologyIndustries: IT Services and IT Consulting #J-18808-Ljbffr

Created: 2025-09-28