ERT Software Quality Assurance Engineer in Boston, Massachusetts

ERT is the leading cloud platform solutions provider that captures quality efficacy and safety endpoints, harmonizes data from any clinical source system, and delivers real-time insights for optimum trial performance – innovating better health for over 40 years and tomorrow. ERT’s combination of technology, services, and consulting increases the accuracy and reliability of patient data and improves the efficiency of the clinical development process throughout the product lifecycle. ERT provides sponsors and CROs with the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments (COAs including patient, clinician, and observer reported outcomes). ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.When getting it done right matters, people count. ERT does technology with a purpose - to improve and save lives. Our important work sets the industry standard in health outcomes research. Our team provides unparalleled scientific and regulatory leadership to pharmaceutical, biotechnology, contract research organizations (CROs) and medical device companies around the world. Our global clients rely upon our expertise - including our ePRO, and Consulting Solutions - to flawlessly expedite their clinical research studies.

eClinical Insights Platform

ERT’s eClinical Insights technology platform delivers visibility and control across the disparate systems and diverse teams being used to conduct clinical trials across the globe. With a proprietary data integration framework, the industry's first cloud-based eClinical data hub, and a turnkey business analytics engine all serving as the core of the platform, our products can interface with any clinical technology a customer is using, and deliver on the mission-critical intelligence that resides in their data with no disruption to underlying systems.

We are looking to build out our team with a Software Quality Assurance Engineer who has excellent technical writing skills, extensive knowledge of software testing methodologies and experience working on agile development teams to streamline software testing processes moving forward. This position will report directly to the Platform Manager.

Duties and Responsibilities

  • Assist in writing software requirements and design documents, test scripts and traceability matrices.

  • Create and maintain functional specifications for study-specific implementations of ERT products and services.

  • Author test plans and summaries to support testing methodologies.

  • Monitor and review all project deliverable quality.

  • Provide risk-based analysis on test coverage and execution.

  • Execution of test scripts including detailed results and screen shots.

  • Work with others on the engineering team to conform to our SDLC.

  • Participate in customer audits and provide quality assurance expertise and direction to project teams.

Other Duties and Responsibilities

  • Manage software testing efforts to schedule and estimates to achieve project deadlines.

  • Strong analytics and problem solving capabilities.

  • Ability to adjust to changing priorities.

  • Desire to be a key player on a small, growing team that is building some great products for clinical research.

  • Ability to execute and deliver to tight guidelines and schedules.

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.

Qualifications

  • Knowledge of computer systems validation requirements for clinical research technologies a plus.

  • Knowledge of FDA Regulations surrounding 21 CFR Part 11 and cGxP a plus.

  • Experience in build automation and test automation technologies a plus.

  • Strong overall experience working on development teams building enterprise web-based and large scale systems.

  • Experience testing SOA based applications a plus.

  • Ability to write complex SQL queries and the ability to analyze the SQL data are required.

  • Previous start-up experience is preferred.

  • Previous experience in Agile, team-based product development is preferred.

  • Experience with cloud-based and SaaS products is a plus.

  • Experience in the clinical research or healthcare industry is a plus.

Education:

  • BS/MS in Computer Science or related field.

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.

Hours: Full-time

External Company Name: eResearch Technology

External Company URL: www.ert.com