US Citizens and Green Card Holders and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time
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 Bachelors 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.
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Medical Device Quality Systems Process Controls Quality Assurance Validation MS Office
12+ Months Contract
Global Technical Talent