Senior Software Quality Assurance Engineer

About the position

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.

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.

Requirements

• 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.

Benefits

• Flexible work schedule with hybrid work model.
• Competitive salary range of $95,600 to $129,100, with higher ranges for specific locations.
• Opportunities for professional development and training.
• Commitment to diversity and inclusion in the workplace.