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Software QA Specialist

GenomeDx Biosciences is a dynamic entrepreneurial startup molecular diagnostics company focused on cancer genomics. Whether on the phone with patients, or in the cloud with big data, our innovators are working hard to give back to the patient what cancer takes away: information for life.

Our team is constantly learning from each other, from patients, and from urologic oncology professionals at world-renowned cancer institutions. We work in multi-disciplinary, collaborative project teams that enable us to respond effectively to an evolving, growing, data-driven environment.

GDx Innovator Profile

We are currently seeking a Software QA Specialist to ensure that software applications developed and configured by the Software Engineering team and/or associated vendors meet specifications, are compliant with applicable regulatory standards, and work as expected & designed.

If you think you have what it takes to be part of an elite group of entrepreneurial innovators we invite you to consider joining the GenomeDx team in our San Diego location.

What you are great at doing: 

  • Performing manual exploratory testing and developing and maintaining automated test suites for various software applications.
  • Documenting test cases, writing test plans, and producing test result reports.
  • Documenting bugs and following bug and issue validation workflows using JIRA or similar issue tracking tools.
  • Making sure team members and stakeholders are notified about software issues.
  • Devising the “right” coverage levels and strategies for each new type of application and workflow.
  • Participating in Agile Scrum sprint planning, design history creation, in-sprint testing, automated regression testing, demonstrations, retrospectives, and solution releases.
  • Performing risk analysis using GAMP 5 or a similar standard.
  • Implementing and following regulatory procedures required by diagnostic medical laboratories (e.g. CLIA, CAP, NYS certification, etc.).
  • Planning and performing load and performance testing, setting up test environments, and estimating time and difficulty for test activities.
  • Communicating effectively with both technical and non-technical audiences, and participating as a member of cross-functional project teams.

What you need to be successful:

  • Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related field; or equivalent education and experience combination.
  • 3-5 Year's Software development background, with a minimum of two years’ experience in Software QA and testing.
  • Background in software validation in a biotech, medical device, medical diagnostics, pharmaceutical, or other regulated industry like aerospace, finance, etc.

What you will bring to the team:

  • Enthusiasm and an entrepreneurial spirit.
  • Familiarity with some of the following: front-end technologies (like Javascript-based frameworks), back-end technologies (like Java, Scala, relational databases, etc.), Amazon Web Services (AWS)/AWS deployment, API/unit/integration testing/validation, web applications and automated testing.
  • Solid experience in functional testing, system integration testing, regression testing, GUI testing, web service testing, and browser compatibility testing.
  • Proven ability to understand complex, distributed software systems for correct operation and performance.
  • Familiarity with elements of the software development life cycle, including planning, development, requirements management, configuration management, quality assurance, and release management.

Bonus Points!

  • Understanding of and experience with medical device software regulations, such as FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, ISO/IEC 12207/14971, and/or IEC 62304.
  • CLIA, LIS and CAP experience a plus.
  • Sales Force experience a plus.

 

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