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.

• 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.

• 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.