Verification and Validation Engineer with Medical Devices Experience

Job Summary The Quality Assurance (QA) Engineer is responsible for developing, executing, and documenting software test protocols to ensure product quality, reliability, and compliance with requirements. This role supports product software and manufacturing process software testing activities, including test method development, verification, validation, and reporting. The QA Engineer works closely with cross-functional teams to identify defects, improve software quality, and ensure successful product releases.

Key Responsibilities

Software Testing & Validation Develop comprehensive software test protocols, test plans, and test cases based on product and system requirements. Execute software testing activities, including functional, integration, system, regression, and user acceptance testing. Document test results and prepare detailed test reports, including defect tracking and resolution status. Analyze test outcomes and provide recommendations for corrective and preventive actions.

Verification & Validation Support the development, verification, and validation of product software test methods. Assist in validating manufacturing process software to ensure compliance with operational and quality requirements. Verify software performance against design specifications, regulatory requirements, and quality standards. Participate in risk assessments and validation activities to ensure software reliability and effectiveness.

Documentation & Compliance Maintain accurate and complete testing documentation in accordance with company quality procedures. Review software requirements, specifications, and design documents to ensure testability and coverage. Support internal and external audits by providing required testing and validation documentation. Ensure adherence to applicable quality management systems and industry standards. Continuous Improvement Identify opportunities to improve software testing processes, tools, and methodologies. Collaborate with development, engineering, manufacturing, and quality teams to resolve software issues. Contribute to process improvement initiatives that enhance product quality and operational efficiency. Perform other software-related outputs and deliverables as reasonably assigned by management.