Software Quality Assurance Engineer

7 days ago


Hayward, California, United States Predicine, Inc Full time
Job Title: Software Quality Assurance Engineer

About the Role: We are seeking an experienced Software Quality Assurance Engineer to join our team at Predicine, Inc.

Job Description: As a Software Quality Assurance Engineer, you will be responsible for developing and implementing software verification and testing systems, working with software and DevOps engineers to automate testing and deployment processes, and writing software and test documentation necessary for compliance with FDA, ISO, and other regulatory organizations.

Responsibilities:

* Develop and implement software verification and testing systems and individual test cases for our commercial bioinformatics and lab software.

* Work with software and DevOps engineers to automate as much testing and deployment processes as possible, using tools such as GitLab and AWS.

* Develop and execute test plans and write individual tests both for single applications, integration testing, and full end-to-end testing.

* Write and deliver software and test documentation necessary such as IQ/OQ and regression testing to achieve and maintain compliance with FDA, ISO, and other regulatory and certification organizations.

* Work with Lab, Engineering, Regulatory, and Quality Assurance teams to define project requirements, design project plans, track project status, and report on progress.

* Advocate for Software Quality, DevOps, Security, and Agile best practices.

Requirements:

* Track record of successfully working with and developing effective software verification and test plans and infrastructure.

* Experience developing, writing, and editing clear and concise Software Development Lifecycle (SDLC) documentation, such as software requirements, risk assessments, and validation reports within a regulated medical device, healthcare, or biotech environment following ISO 13485 Design Controls.

* Professional experience in several programming languages, including Python.

* Experience working with databases, web apps, and command-line tools on a Linux system.

* Strong debugging and troubleshooting skills to identify the root cause of issues quickly in complex software systems.

* BS degree or higher in Computer Science, or equivalent training and experience.

* 6+ years of professional engineering experience.

* 4+ years of professional Quality Assurance, Test, or Regulatory experience.

What We Offer:

* Salary Range for this position: 122K-188K

* Candidate location: California, other locations may be considered.

* All full-time roles in the US come with a robust benefits package which includes healthcare, dental, and vision insurance. Additional benefits include PTO, paid holidays and 401(k) retirement plan.

About Predicine, Inc:

Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. We have developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection.

Equal Opportunity Employer:

We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.

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