Software Quality Engineer

Flex•Buffalo Grove, IL

4d•Onsite

About The Position

The Software Quality Engineer will be based in Buffalo Grove, IL. In this position you will be responsible for providing technical and implementations support for our Enterprise Integration Systems and applications. You will also be responsible for architecting, designing, installation, and set-up of our enterprise applications.

Requirements

Bachelor’s degree in information technology, Computer Science, or a related field, or equivalent combination of education and relevant work experience.
5+ years of experience in software validation for enterprise systems, including Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), and Quality Management Systems (QMS).
Strong knowledge of GAMP categorization, Computer System Validation (CSV), Computer Software Assurance (CSA), 21 CFR Part 11, and 21 CFR Part 820 requirements.
Proven experience applying risk-based validation methodologies and developing validation strategies for regulated environments.
Hands-on experience with validation planning, test design, execution, defect management, and validation reporting.
Ability to analyze business and functional requirements and translate them into comprehensive validation documentation and deliverables.
Experience creating, reviewing, and maintaining testing documentation and Software Lifecycle (SLC) artifacts.
Solid understanding of IT environments, application support, and system maintenance best practices.
Excellent verbal and written communication skills with exceptional attention to detail and strong organizational abilities.

Responsibilities

Lead software validation activities, including validation strategy, test planning, test design, execution, defect management, and reporting.
Apply GAMP categorization, CSV/CSA methodologies, 21 CFR Part 11 requirements, and risk-based validation principles to ensure regulatory compliance.
Analyze user and functional requirements, estimate testing efforts, and contribute to project planning and validation strategies.
Prepare, review, and maintain Software Lifecycle (SLC) and validation documentation throughout the project lifecycle.
Execute validation activities in accordance with approved procedures, quality standards, regulatory requirements, and organizational policies.
Coordinate defect triage, analyze test results, and collaborate with cross-functional teams to resolve issues efficiently.
Monitor validation progress and provide accurate daily, weekly, and monthly status reports to stakeholders.
Ensure timely delivery of high-quality validation outcomes while maintaining compliance with FDA regulations and internal quality standards.
Define, design, implement, and validate computerized systems in compliance with FDA regulations and change control processes.
Develop and implement Validation Master Plans (VMPs) and overall validation strategies.
Support the creation, execution, review, and approval of all software validation deliverables throughout the Software Verification and Validation (SV&V) lifecycle.
Perform independent reviews and approvals of validation documentation to ensure completeness, accuracy, and compliance.
Develop and review validation protocols to ensure testing adequately verifies intended system functionality and regulatory requirements.
Review executed protocols and validation reports for compliance with Good Documentation Practices (GDP), validation standards, and justified conclusions.
Provide guidance on incident, deviation, and defect management, ensuring timely resolution and appropriate documentation.
Identify, assess, and mitigate project and validation risks while recommending effective solutions.
Support and participate in Corrective and Preventive Action (CAPA) investigations and document IQ/OQ/PQ protocols and validation reports.
Ensure solution stability through appropriate monitoring, controls, and continuous process improvements.
Promote knowledge sharing of new technologies, systems, and validation best practices across the team.
Establish effective communication channels and maintain strong collaboration with customers, peers, and cross-functional stakeholders.