Senior Software Quality Assurance Engineer

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 postmarket risk assessments including Hazard Analysis/dFMEA/uFMEA/ COTS/SOUP Risk Analysis

Support the verification and validation strategy for development projects in an FDAregulated environment including medical device software and nonmedical 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 GxPrelated 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 postproduction.

Contribute to longterm 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 crossfunctional teams to author and manage Corrective Action Preventive Action (CAPA) and Nonconformance Event Management (NER) reports.

Perform additional duties as assigned.

Qualifications :

 Bachelors degree or higher in Biomedical Engineering Computer Science Engineering or a related field or equivalent project experience. (Masters 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 rapidpaced startup environment e.g. Agile/Scrum

Detailfocused 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.

Additional Information :

Hybrid Work Model: At Guardant Health we have defined days for inperson/onsite collaboration and workfromhome days for individualfocused 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 inoffice 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 worklife balance while keeping teams connected to advance our science for our patients.

The US base salary range for this fulltime position is $95600 to $129100. 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 fulltime position is $119500 to $161370. 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 jobrelated 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 longterm conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to 

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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