• Project Software Quality Engineer

    Job Location US-PA-Pittsburgh
    Regular Full-Time
  • Overview

    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.

    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.


    The Project Software Quality Engineer works on a team of quality engineers responsible for the validating of mobile device and web-based software applications specifically developed for ERT’s clients. This individual will take ownership of projects, review requirements and specifications for clarity, plan the testing approach, design test cases, and supervise execution of testing. 


    Essential Duties and Responsibilities:

    1. Serve as a subject matter expert in cross-functional collaborations with other ERT departments and groups in the development of best practices and process improvements.
    2. Create the Test Plan and Test Summary and Requirements to Test Script Traceability documents.
    3. Assign and coordinate testing tasks and monitor their efficiency and quality. This also includes follow-up on defects in the defect tracking system to help triage priority and disposition.
    4. Collaborate with software and data delivery engineers to understand the changes in new software versions and identify the appropriate set of functional and regression tests needed to verify that new features function as designed and do not cause any undesirable behavior.
    5. Provide software quality feedback to the project team, including the project manager, engineers and QA Manager.
    6. Recommend quality improvements or changes to development processes, procedures, and systems and software products to correct known or potential deficiencies.
    7. Provide accurate and timely input into the time reporting system, and manage applicable tasks in the project management system.
    8. Attend project meetings and manage SQE effort for multiple assigned projects running simultaneously.
    9. Participate in requirements and design specification reviews.
    10. Conduct integration, functional and stress tests for database, web-based and handheld applications and hardware.
    11. Follow all testing practices and procedures to meet regulatory compliance standards and Good Clinical Practices.


    The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.


    1. BS, BA or equivalent in an Information Technology or related field required.
    2. 5 years of software quality assurance experience. Strong skills in creating test plans, performing testing and maintaining detailed documentation.
    3. Self-starter with the ability to work with little or no direct supervision, as well as the necessary communication skills to interface directly with the development staff and communicate effectively about project issues.
    4. Experience finding, reproducing, logging and verifying software defects.
    5. Experience providing and seeking peer reviews of test plans to improve quality.
    6. Ability to work in a fast-paced and constantly changing environment, and manage multiple projects simultaneously.
    7. Ability to work under pressure and meet deadlines.
    8. Ability to carefully examine requirements specifications to anticipate quality issues and provide timely feedback when specifications are incomplete or inaccurate.
    9. Must be detail oriented, organized have the ability to learn new tasks quickly and exhibit a positive attitude.
    10. Excellent oral and written communication skills.




    1. Experience testing handheld devices with hardware and software components.
    2. Experience testing web-based software applications.
    3. Experience testing software for clinical trials or the pharmaceutical industry.
    4. Software testing experience in a regulated environment (ISO 9001, FDA 21 CFR Part 11).
    5. Working knowledge of software tools such as a Visual SourceSafe, GIT, JIRA, Jama and Rational ClearQuest.
    6. Working knowledge of test automation scripting with keyword based platforms.
    7. Experience with custom database query development, experience with Microsoft Office, especially Word, Excel, and Outlook.
    8. Experience with applications that use a relational database back-end such as Microsoft SQL.


    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 


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