Senior/Lead Software Quality Engineer

Title Senior/Lead Software Quality Engineer Location: 6101 Stoneridge Dr, Pleasanton, CA USA 94588 Duration: 12 Months | 100% Onsite Pay Range: $55/ hr to $57/ hr (On W2) We are looking for a “Senior/Lead Software Quality Engineer” to join one of our Leading Healthcare Client. Overview Seeking a Senior/Lead Software Quality Engineer to support software quality activities, ensure regulatory compliance, and collaborate across teams in product development and manufacturing. Key Responsibilities Develop 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 Qualifications Bachelor’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 Qualifications ASQ CSQE certification. Experience in large enterprise/cross-division environments. Strong communication, organizational, and multitasking skills. Ability to adapt in fast-paced, regulated environments. We are looking for the candidate who are eligible to work with any employers without sponsorship. If you’re interested, please click “Apply” button.

Created: 2025-10-01