Senior Software Quality Assurance Engineer - job 3 of 3

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

The Software Quality Assurance Engineer will be responsible for performing or reviewing software and computer system Verification and Validation (V&V), software 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.

Essential Duties and Responsibilities:

· Primary point of contact for all software quality activities related to the Guardant Health IVD and LDT development activities which include providing guidance for Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.

· Lead pre and post-market risk assessments including Hazard Analysis/dFMEA/uFMEA/ COTS/SOUP Risk Analysis

· Support the verification and validation strategy for 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)

· Review Software Architecture and Design (SAD) Software Design Specification (SDS), test plans and protocols, test reports, and trace matrices for multiple software components as part of a larger system

· Be the quality advocate and enforce standards within the software development life cycle (SDLC)

· 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.

· Review, track and escalate anomalies discovered during testing and post-production.

· 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.

· Perform additional duties as assigned.

 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 5 years of experience working with Software as a Medical Device or Software in a Medical device or In Vitro Diagnostic (IVD)

· A 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 PART 11)

· Experience in leading risk management activities pr ISO 14971:2019 + A11:2021

· 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)

· 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

Work Environment:

· Employee may be required to lift routine office supplies and use office equipment. The 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.

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.

The US base salary range for this full-time position is $95,600 to $129,100. 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 with the exception of any locations specifically referenced below (if any).

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $119,500 to $161,370. The range does not include benefits, and if applicable, bonus, commission, or equity.

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.

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 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 [email protected]

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.

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