Software Validation Engineer

Job Title: Software Validation Engineer Location: Santa Clara, CA (Onsite)

Experience: 4 - 8 Years

Role Overview

We are seeking a Software Validation Engineer to manage non-product software quality and validation within a medical device environment. This role ensures compliance with FDA, ISO 13485, IEC 62304, 21 CFR Part 11, and GxP/GAMP standards. The SQA Engineer will support audits, CSV activities, and drive continuous improvement across SDLC and IT tools.

Key Responsibilities:

Develop, implement, and maintain SQA processes for non-product software, including development, testing, and maintenance tools.

Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, 21 CFR Part 11, and GxP/GAMP standards.

Support audits and inspections, maintaining required documentation.

Lead Computer System Validation (CSV) activities:

Conduct Applicability and Criticality assessments (GxP & Part 11).

Author and review URS/FRS, Validation Plans, IQ/OQ/PQ Protocols, Summary/Exception Reports, and Traceability Matrices.

Execute dry/test protocols, perform periodic reviews, and manage system retirement/decommissioning.

Partner with Software and IT teams to ensure QMS alignment and best practices.

Drive continuous improvement initiatives in software quality and compliance.

Qualifications

• Required:

• Bachelor’s degree in Engineering, Science, or related field.

• 4–5+ years of experience in SQA/Software Validation (medical device experience preferred).

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304.

• Experience validating non-product software (tools supporting development, testing, or maintenance).

• Preferred:

• Hands-on CSV experience (GxP & Part 11 assessments; URS/FRS, Validation Plans, Protocols, Reports, RTM; Periodic Reviews; System Retirement).

• Familiarity with PLM, JIRA, JAMA; test automation exposure.

• Solid understanding of SDLC for computerized systems.