Quality Assurance Engineer

Job Summary

Supporting the implementation and validation of a replacement Product Lifecycle Management (PLM) system, the remote contract Quality Assurance Engineer will focus on computer system validation (CSV), including documenting user requirements, supporting PLM configuration, and developing User Acceptance Testing (UAT) deliverables.

Key responsibilities

• Collaborate with Business Analysts to translate business needs into clear, testable functional requirements and system specifications
• Develop functional test scripts and support UAT planning, execution, and defect management
• Author and maintain validation documentation to ensure compliance with internal Quality Management System (QMS) and regulatory requirements

Required qualifications

• BS in computer science, engineering, business, or a related discipline
• 3+ years of experience in Computerized Systems Validations (CSV/CSA) with a strong emphasis on document authoring
• Experience in a regulated environment (cGMP, cGDP, and 21 CFR part 11 regulations) is preferred
• Hands-on experience with PLM software implementation and validation, including authoring test scripts and documentation
• Familiarity with GxP/FDA-regulated systems and UAT planning and testing tools