Experis
Overview
Senior/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. Location
6101 Stoneridge Dr, Pleasanton, CA 94588, USA Duration:
12 Months | 100% Onsite Pay Range:
$55/hr to $57/hr (On W2) 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. Eligibility
We are looking for candidates who are eligible to work with any employer without sponsorship. How to apply
If you’re interested, please click “Apply”. Job details
Seniority level: Mid-Senior level Employment type: Contract Job function: Engineering and Information Technology Industries: IT Services and IT Consulting
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Senior/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. Location
6101 Stoneridge Dr, Pleasanton, CA 94588, USA Duration:
12 Months | 100% Onsite Pay Range:
$55/hr to $57/hr (On W2) 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. Eligibility
We are looking for candidates who are eligible to work with any employer without sponsorship. How to apply
If you’re interested, please click “Apply”. Job details
Seniority level: Mid-Senior level Employment type: Contract Job function: Engineering and Information Technology Industries: IT Services and IT Consulting
#J-18808-Ljbffr