Software Quality Assurance Engineer
Employment Type: Full-Time
Industry: Information Technology
Software Quality Engineer
Tracking Code 491-093 Job Description
Developing new and innovative medical diagnostic products requires an exceptionally skilled team, with a creative approach to overcoming challenges, and a commitment to improving healthcare for the benefit of patients, practitioners and healthcare institutions.
We are seeking an experienced software quality engineerwho is excited about the work we do at T2 Biosystems and will work as part of our Engineering team to verify, validate and release software updates, in compliance with our Quality System. This position reports to the Director of Software Engineering and is based in Lexington, MA.
The ideal candidate will have strong organizational and communication skills (verbal and written), a meticulous, detail-oriented work approach and be comfortable following a regulated, formal development and release process.
- Create, execute, and document functional test protocols for new and existing software.
- Maintain product requirements, trace matrices, test reports, work instructions and other product documentation in compliance with FDA and ISO/CE regulations, and internal development processes and design controls.
- Prepare release documentation including release notes, risk assessments and other deliverables and drive releases through the Change Order process.
- Maintain records and work in a biological laboratory using Standard Laboratory Practices.
- Identify, analyze, track and document software defects. Assist in software troubleshooting for internal users.
- Other tasks as needed.
Skills and Experience:
- Bachelors degree in Computer Science, Engineering or relevant Life Science discipline
- 1-3 years of relevant job experience with functional device testing in a laboratory setting or similar controlled development environment
- Experience working in medical device development R&D or QA department
- Must be comfortable working with blood and other biological substances in a controlled environment
- Design Control, Software Lifecycle and Change Management experience required
- Experience with Agile software development processes.
- Proficient with Microsoft Office.
- Experience with Arena and Rally or other Product Lifecycle Management and Defect Tracking tools.
- Experience with FDA 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 is a strong plus
Job Location Lexington, Massachusetts, United States Position Type Full-Time/Regular
Associated topics: automation, performance test, process, prevention, quality, quality assurance analyst, software quality, software quality assurance, software quality assurance engineer, tester
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