Responsibilities
As a Software Quality Engineer, you will play a crucial role in championing quality assurance and engineering activities for sustaining projects. Collaborating with our software organization, you will focus on maintaining and enhancing existing software applications, resolving issues and defects, and ensuring compliance with Verily’s procedures. This contract position provides an exciting opportunity to contribute to the enhancement and maintenance of digital health solutions that directly impact patient care and well-being.
Software Maintenance and Support: Provide ongoing maintenance and support for existing software applications in a sustaining environment.
Design History File Management: Maintain the Design History File, including software development plans, verification and validation plans, requirements specifications, architecture and design documents, and conduct design and code reviews.
Defect Analysis and Troubleshooting: Identify, document, and analyze software defects or issues reported by users or identified internally. Perform thorough root cause analysis to understand the underlying problems and collaborate with the team to resolve them.
Continuous Improvement: Continuously assess and improve software design quality processes for the sustaining project. Identify areas for process enhancement, automation, and efficiency gains to optimize software maintenance and support activities.
Requirements
BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, or a related technical field, or equivalent practical experience.
3+ years of experience in software design assurance in the healthcare or pharmaceutical industry, with a focus on clinical trial software management.
Knowledge of quality management systems (e.g., ISO 13485) and standards (e.g., 21 CFR Part 11). Understanding of quality assurance processes, change control, and configuration management in a regulated environment.
Familiarity with data management practices, data integrity principles, and security measures applied to clinical trial data.
Experience with electronic data capture (EDC) systems and their validation.
Project management experience, along with the ability to train and collaborate effectively with software development teams.
Exposure to digital health, Health IT, or mobile medical applications.
Availability to work directly as an employee of Genesis10 will be considered.
Desired
Experience working with cutting-edge technologies in a lean, fast-paced, and highly innovative environment.
Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14971 (Risk management), and IEC 62366 (Usability Engineering).
Demonstrated ability to implement and improve Software QMS processes using SDLC best practices, tools, and agile/scrum/iterative methodologies.
Excellent organizational, interpersonal, verbal, and written communication skills, with a track record of delivering quality outputs under minimal supervision.
Join our team and make a meaningful impact in the world of healthcare through innovative software quality engineering. We offer a dynamic work environment, a chance to collaborate with brilliant minds, and an opportunity to shape the future of precision health.
Employment Type: Full-Time
Salary: $ 77.00 88.00 Per Hour
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