Job Description

Guardant Health is looking for an energetic and passionate Staff QA Engineer to join its growing Software Quality Engineering team. This team is responsible for delivering the product functionality needed to support the laboratory workflow for a number of its market leading cancer diagnostic tests as well as integration with various oncology systems.

An Ideal candidate would have experience working in a regulated environment with thorough knowledge of Quality Engineering best practices and technical expertise to deliver software products meeting the business needs in an efficient and fast paced environment. This role requires someone who is adept at understanding system architecture, design, implementation to succinctly develop tailored test strategy and deliver quality software products meeting regulatory standards. The candidate should have the aptitude to work on parallel projects with overlapping schedules, quickly learn new technologies, demonstrate teamwork and technical leadership.

RESPONSIBILITIES:

●      Primary role as a functional tester with potential for some aspects of automation.

●      Provide coaching to other team members for designing test strategies and test cases.

●      Participate in the Agile scrum team and work on Software Quality Engineering tasks.

●      Design and execute test coverage for various functional and integration aspects of the Enterprise Lab Information Management System (LabVantage).

●      Partner with software development teams and stakeholders to ensure Company Lab Information Management System of highly complex genetic data meet or exceed our quality standards.

●      Apply appropriate test methodologies including but not limited to writing test plans, test cases, and execution of test scripts within the sprint schedule.

●      Create test cases in Jama and execute them to support scheduled releases.

●      Troubleshoot issues identified during testing and report defects; able to distinguish between user error and application anomalies.

●      Perform System Integration testing at the end of functional sprints prior to product release.

●      Provide clear and concise feedback on defects, usability, and other test findings/results.

●      Identify and advocate testing standards and processes as needed within the team.

●      Collaborate with cross-functional teams to ensure timely and robust execution of testing as part of a regular release schedule.

●      Execute complex testing scenarios, perform in-depth statistical analysis, and interpret results independently.

●      Establish cross-functional relationships across business and technical leads, architects, and product owners to ensure alignment with business goals and enterprise-level architectural standards.

●      Apply QE standards, best practices, and principles to develop quality plans that deliver optimal outcomes across multiple products.

●      Deliver test documentation to support software development for medical devices in compliance with FDA, CE mark, IEC 62304, PMDA and ISO 13485 standards.

Qualifications

●      12+ years of hands-on testing experience in Service Oriented Architecture environment using COTS/SaaS solutions with API led integrations.

●      8+ years of experience in test preparation activities within an Agile Development Process – Test Design, Test scripting, Test Data creation.

●      6+ years of experience in testing integrations in a hybrid environment leveraging XML/JSON message formats.

●      6+ years of experience using databases like Postgres, Oracle, MSSQL Server or MongoDB.

●      6+ years of API test tools like Postman, Fiddler, SOAPUI required.

●      Proven ability to adapt to new technologies and design test strategies.

●      Extensive experience in good testing practices and methodologies.

●      Excellent communication, presentation, and analytical skills, including strong ability to identify and solve ambiguous cross-functional software quality related problems.

●      Expertise in measuring and reporting quality-related metrics to identify trends, anomalies and proactively resolve problems.

●      Experience in identifying, analyzing, and narrowing down system integration issues and performing root cause analysis.

●      Expertise in developing and maintaining SDLC documentation such as Verification Plan, Report, Risk Assessment and Traceability Matrix, etc.

●      Ability to deliver software releases in frequent cycles using agile methodology.

●      B.S. or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience.

DESIRABLE, BUT NOT REQUIRED:

●      5+ years of performing verification and validation activities in medical device, pharma or healthcare regulated environment.

●      Designed test automation to support CI/CD pipeline for software delivery.

●      Experience working in a regulated environment (CLIA, CAP, HIPAA, SOX, 21 CFR Part 11, ISO 13485, IEC 62304, and other FDA regulations) is desired.

●      Experience in testing HL7 message format.

●      Working experience in MuleSoft platform.

Additional Information

HYBRID WORK MODEL: AT GUARDANT HEALTH, WE HAVE DEFINED DAYS FOR IN-PERSON/ONSITE COLLABORATION AND WORK-FROM-HOME DAYS FOR INDIVIDUAL-FOCUSED TIME. ALL U.S. EMPLOYEES WHO LIVE WITHIN 50 MILES OF A GUARDANT FACILITY WILL BE REQUIRED TO BE ONSITE ON MONDAYS, TUESDAYS, AND THURSDAYS. WE HAVE FOUND ALIGNING OUR SCHEDULED IN-OFFICE DAYS ALLOWS OUR TEAMS TO DO THE BEST WORK AND CREATES THE FOCUSED THINKING TIME OUR INNOVATIVE WORK REQUIRES. AT GUARDANT, OUR WORK MODEL HAS CREATED FLEXIBILITY FOR BETTER WORK-LIFE BALANCE WHILE KEEPING TEAMS CONNECTED TO ADVANCE OUR SCIENCE FOR OUR PATIENTS.

COVID VACCINATION POLICY: STARTING JANUARY 7, 2022, GUARDANT HEALTH WILL REQUIRE ALL EMPLOYEES TO BE FULLY VACCINATED TO EITHER (A) ESTABLISH THAT THEY HAVE BEEN FULLY VACCINATED AGAINST COVID-19; OR (B) REQUEST AND OBTAIN AN APPROVED EXEMPTION FROM GUARDANT’S COVID-19 U.S. VACCINATION POLICY AS A REASONABLE ACCOMMODATION.  AN EMPLOYEE IS CONSIDERED FULLY VACCINATED AGAINST COVID-19 TWO WEEKS AFTER RECEIVING THE SECOND DOSE OF A TWO-DOSE VACCINE OR ONE DOSE OF A SINGLE-DOSE VACCINATION. ACCEPTABLE VACCINES ARE APPROVED OR UNDER EMERGENCY USE AUTHORIZATION BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND/OR THE WORLD HEALTH ORGANIZATION (WHO). IN ADDITION, FULLY-VACCINATED EMPLOYEES WILL BE REQUIRED TO MAINTAIN THEIR FULLY-VACCINATED STATUS UNDER THIS POLICY BY OBTAINING, IF APPLICABLE, ANY FDA-APPROVED BOOSTERS.

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. 

The US base salary range for this full-time position is $95,760 to $148,000. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role.

Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com

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. Please visit our career page at: http://www.guardanthealth.com/jobs/

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