Software Quality Engineer
ERT's Software Quality Engineer facilitates the validation of initial releases of study software, reports, translations and change control, as well as to review and approve the CSV package according to the SOPs and Work Instructions. The SQE will also manage the overall test effort for assigned projects.
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.
In this role, you will:
- Create the Test Plan and Test Summary and Requirements to Test Script Traceability documents.
- 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.
- 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.
- Provide software quality feedback to the project team, including the project manager, engineers and QA Manager.
- Recommend quality improvements or changes to development processes, procedures, and systems and software products to correct known or potential deficiencies.
- Provide accurate and timely input into the time reporting system, and manage applicable tasks in the project management system.
- Attend project meetings and manage SQE effort for multiple assigned projects running simultaneously.
- Participate in requirements and design specification reviews.
- Conduct integration, functional and stress tests for database, web-based and handheld applications and hardware.
- Follow all testing practices and procedures to meet regulatory compliance standards and Good Clinical Practices.
- On an as needed basis, write test cases and execute test cases.
- Participate in projects related to company-wide Continuous Improvement Program as assigned by the manager.
- Participate in cross-training activities, e.g. translations, formatting, package building/testing, etc.
- Create and/or run reports on the project management system and defect tracking system as requested.
- Mentor co-workers on areas of your expertise.
- The duties and responsibilities listed in this job description represent the major responsibilities of the position. ERT reserves the right to amend or change these duties. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
- Our ideal candidate will offer:
- BS, BA or equivalent in an Information Technology or related field required.
- 1-3 years software testing experience preferred. Strong skills in creating test plans, performing testing and maintaining detailed documentation.
- Ability to carefully examine requirements and specifications to anticipate quality issues and provide timely feedback when specifications are incomplete or inaccurate.
- Experience finding, reproducing, logging and verifying software defects.
- Ability to work in a fast-paced and constantly changing environment, and manage multiple projects simultaneously.
- Ability to work under pressure and meet deadlines.
- Must be able to communicate and work with an offshore team when necessary
- Must be detail oriented, organized, able to learn new tasks quickly and exhibit a positive attitude.
- Excellent oral and written communication skills.
- Other highly desirable skills or experience include:
- Experience testing handheld devices with hardware and software components.
- Experience testing web-based software applications.
- Experience testing software for clinical trials or the pharmaceutical industry.
- Software testing experience in a regulated environment (ISO 9001, FDA 21 CFR Part 11).
- Working knowledge of software tools such as a Visual SourceSafe, GIT, JIRA and Rational ClearQuest.
- Experience with Microsoft Office, especially Word, Excel, and Outlook.
- Experience with applications that use a relational database back-end such as Microsoft SQL.
- 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.
- Experience providing and seeking peer reviews of test plans to improve quality.
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.