Senior Software Quality Assurance Engineer

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Job Description

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.

Qualifications

 Bachelor’s degree or higher in Biomedical Engineering, Computer