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Validation Software Engineer I (QMS)
Ref No.: 18-12586
Location: San Diego, California
Software Validation Engineer (2)
• Develop, review and approve of validation documents such as Operation Qualification Plan, Operation Qualification Reports, Protocol Qualification Reports, Protocol Test Script and Installation Qualification Execution Report.
• Implement validation activities, common operation qualification test execution, test script and acceptance testing,
• Report software validation test results in structured way plus suggest on deliverables quality internal
• Comply with company guidelines and policies utilizing software validation process and work instructions.
• Demonstrates mastery in software testing and interpretation of End user requirements.
• Creates Operation qualification test cases and executes tests cases.
• Facilitate functional risk assessment (if applicable)
• Assists the Software Validation Group Leader in software test planning as a member of the team.
• Report about product quality to project management as required.
• Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.
• Learn and understand the applicable technology and engage in technical discussions.

Requirements and Education
• Requires a Bachelor’s degree in engineering or science and a minimum of 2 years of related experience.
• Experience in medical device industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods is strongly preferred
• 2-5 years in quality assurance engineering experience in an FDA regulated environment is strongly preferred.
• Intermediate knowledge and working application of Validation Principles and guidelines and industry practice
• Knowledge and working application of standard operating procedures.
• Demonstrated ability to accomplish goals while working across departments is required.
• Computer competency in MS Office.
• Excellent interpersonal, written, and verbal communication skills.
• Adaptable to fast-paced, dynamic work environment with ability methodically manage projects.