Manager, Software Quality Engineering
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.
ERT is looking for a Manager, Software Quality Engineer to oversee the engineering of software quality for a specific product or service group made up of software quality engineers, technicians and/or support personnel. Must be a very hands-on QA engineer with core focus around automation and QA processes.
- Provide direction, assign tasks and coordinate the work of QA team members in the context of a fast-paced, Agile development process.
- Coordinate a formal process of estimating the scope and duration of testing projects. Establish milestones, timelines and maintain progress reporting.
- Oversee completion of tasks of the QA team on time and within budget. Resolve prioritization and assignment issues and provide performance mentorship to team members.
- Collaborate with development team and product management 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 of test plans and summaries to support testing methodologies
- Collaborate with the product owner and department management to resolve technical challenges and remove process obstacles to insure integration of the deliverables inside and outside the organization upon release.
- Provide risk-based analysis on test coverage and execution.
- Ensure the execution of the test plan including detailed documented results and screen shots.
- Participate in customer audits and provide quality assurance expertise and direction to project.
- May employ manual or automated testing procedures.
Other Duties and Responsibilities:
- Responsible for the training and development of all new staff members regarding departmental resources and procedures.
- 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.
- BS/MS in Computer Science or related field
- 8-10 years’ experience in professional software development or quality engineering as part of a larger software engineering function following a documented development life cycle.
- Knowledge of computer systems validation requirements for clinical research technologies and FDA Regulations surrounding 21 CFR Part 11 and cGxP
- Experience in build automation and test automation technologies
- Previous experience in Agile, team-based product development is preferred
- Experience with cloud-based and SaaS products
- Ability to execute and deliver to tight guidelines and schedules
- Excellent verbal and written communication skills, including ability to communicate effectively in English
- Strong analytics and problem solving capabilities
- Ability to adjust to changing priorities
- Ensure compliance with timely completion of training and documentation.
ERT is an equal opportunity employer and all qualified applicants 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.