Senior Software Quality Assurance Engineer

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

At Guardant Health, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful and meaningful technologies for cancer management.

To support Guardant Health’s leadership in disruption of cancer treatments, the Quality and Regulation team is looking for an experienced and energetic Software Quality Assurance (SQA) Engineer to help drive software quality and continuous integration and improvement for an exceptional customer experience.

The Software Quality Assurance Engineer will be responsible for performing or reviewing software and computer system Verification and Validation (V&V), test execution, system risk assessments, audit remediation, and documentation authoring (SOPs, Work Instruction, FMEA, COTS/SOUP, Verification Validation Plan, Protocol, Report, traceability matrix, forms, etc.) in accordance to the relevant US FDA regulations, Medical Device regulations in other markets and relevant international standards. In addition, the SQE will work on other software components of the Guardant software stack and ensure that the software verification and validation is complete, the product is safe and of high quality, and meets all regulatory requirements.

As a member of the team, you will:

• Work with contract partners, development engineers, clinical teams, and/or product managers to resolve issues related to usability, requirements, software, scope, schedule, and resources
• Support and participate in requirements analysis, use case development and risk / hazard analysis (FMEA)
• Lead and support the verification and validation strategy for system development projects in an FDA regulated environment including medical device software and non-medical device software that meet internal quality requirements and regulatory standards (e.g., ISO 13485, FDA 21 CFR 11, FDA 21 CFR 820, ISO 14971, IEC 62304)
• Be responsible for creating or ensuring clear and concise test plans and protocols, executing protocols, and generating test reports and trace matrices for multiple software components as part of a larger system
• Understand and embrace Design Controls Process and Software Validation Process for software projects
• Be the quality advocate and enforce standards within the software development life cycle (SDLC)
• Learn and work with leading technologies and dataset (human genomics)
• Work closely with and lead internal and cross-functional teams to set up test environment, prepare test data, draft test cases/protocol and perform test execution, ensure timely and robust execution of testing as part of a regular release schedule and CLIA, IVD, or other regulatory submission
• Provide accurate planning, clear strategies, and milestones for testing leading to successful implementation and timely project completion
• Author a full suite of the software and computer system verification and validation documents (Verification Validation Plan, Protocol, Report, traceability matrix), and perform/document Risk Assessments (FMEA) and COTS/SOUP Risk Analysis
• Assist, review, and edit Software Architecture and Design (SAD) and Software Design Specification (SDS) and other technical documents
• Write, review, update, and maintain GxP related process documentation (SOPs, Work instructions, Forms, etc.), such as Software Change Management, Software Development Life Cycle (SDLC), Configuration Management, Defect Management, etc. and provide training on these processes
• Assist with defining and implementing software quality improvement initiatives
• Train and mentor internal team on regulatory/compliance processes, concepts and best practices, including Software Development process, V&V, Change Management, and Configuration Management processes
• Provide guidance to internal IT team on V&V, Change and Configuration Management. Review and edit V&V documentation from internal teams
• Report, track and escalate anomalies discovered during testing (all testing phases) and ensure closure on issues
• Contribute to long-term planning and streamlining of the Computer System Verification and Validation procedures to increase efficiency in a compliant manner
• Participate and provide solutions to address internal and external audit findings with process enhancements and additional V&V activities, including V&V Plan, testing, and report
• Work with cross-functional teams to author and manage Corrective Action Preventive Action (CAPA) and Nonconformance Event Management (NER) reports
• Identify program deviance from standards and suggest modifications to ensure compliance
• Perform additional duties as assigned

You have the ability to understand system architecture, design, implementation and succinctly develop or review test approach and test cases to deliver high-quality results.

You can work proactively, independently, efficiently and as part of a team on multiple tasks and projects, and quickly learn new technologies.

You enjoy an agile, fast paced and highly technical environment with control implemented for a regulated industry. You are comfortable with receiving and providing constructive feedback.

In addition you bring:

• Bachelor’s degree or higher in Biomedical Engineering, Computer Science, Engineering, or a related field or equivalent project experience. (Master’s degree may be equal to 2 years of working experience.)
• A minimum of 4 years of experience in Computer System Validation or relevant SQA projects in the medical device or In Vitro Diagnostic (IVD) field
• Clear understanding of the SDLC process
• Working knowledge of applicable regulations and procedures (e.g., IEC 62304, ISO 13485, CLIA, FDA, GxP, and 21 CFR 11)
• Experience authoring SOPs, forms, Validation Plan/Report, User Acceptance Testing (UAT), and training materials
• Working knowledge of Corrective Action Preventive Action (CAPA) and Nonconformance Event Reporting (NER)
• Strong experience in UAT and testing of custom, complex business applications
• Prior exposure to programming and scripting languages such as Java, Ruby, Python, Shell is a plus
• Knowledge of RDBMS (SQL or Oracle) and running software via the Linux command line is a plus
• Experience with API testing using tools such as Postman, Advanced REST Client, SoapUI is a plus
• Highly proficient in MS Word, Excel, and PowerPoint
• Ability to articulate complex technical problems and business value to a wide audience
• Ability to summarize technical information to a variety of functions
• Ability to work well in a rapid-paced, start-up environment, e.g. Agile/Scrum
• Detail focused with excellent communication and documentation skills

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

#LI- MR2

Guardant H