Software Quality Engineer
SOFTWARE QUALITY ENGINEER
Freenome’s Software Quality Engineer will support the company’s quality and regulatory activities with various authorities, such as the FDA, CLIA, CAP, and including quality systems such as GMP, IVDR, and ISO, as appropriate. Working with the cross-functional team of Engineering, IT Infrastructure, Regulatory Affairs and Quality, you will be responsible for supporting regulatory and software quality activities, especially in the areas of frontend User Interface (UI), Ordering and Computer System Validation (CSV), RWD/RWE.
How you’ll contribute:
The Software Quality Engineer is an integral member of Freenome’s QA/RA team. You’ll make a significant contribution to our mission of empowering everyone with the tools they need to detect, treat, and ultimately prevent cancer. In this tactical role, you will support software quality engineering initiatives, including Software Development Lifecycle (SDLC) processes, Software Requirements Analysis, Software Validation, Software Risk Management, Software Defect Tracking, Non-Product Software/Computer System Validation, among others. The following list details the core focus and responsibilities:
- Support development of SDLC processes under the quality management systems necessary for compliant software development, validation and verification, especially with respect to UI and CSV, including processes for maintenance, change management and disaster recovery
- Participate in engineering reviews of software requirements analysis, including the traceability to the risk mitigations and software test cases
- Work with team(s) on regulatory and quality strategies and their execution, especially in support of RWD/RWE, laboratory, equipment, and IT infrastructure software
- Support necessary requirements for 21 CFR Part 11 and/or GAMP5 compliance; including data storage, retention, and retrieval
- Support software defect tracking and monitoring with engineering
- Provide support during inspections and audits, leading those related to UI, and Computer System Validation
Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.
What you’ll bring:
- Minimum degree requirement: Bachelor of Computer Sciences, Computer Engineering, or relevant disciplines
- 4 or more years in a regulated life sciences company, in particular medical devices
- Experience working on QA for RWD/RWE FDA submissions
- Knowledge of Software Quality Engineering fundamentals, including software requirements analysis, code review, hazard/risk analysis, software test, among others
- Knowledge of IEC 62304, and/or FDA’s General Principles of Software Validation guidance document
- Knowledge of ISO 13485 and 21 CFR Part 820
- Knowledge of CLIA, CAP, and the NYSDOH
- Well versed in 21 CFR Part 11 and/or GAMP5
- Proven track record of software testing, verification and validation experience
The followings are nice-to-have and will certainly make your qualification a big-plus:
- Experience with HL7 and/or FHIR, HIPAA, and Electronic Medical Records (EMR)
- Experience with Lab Ordering and Report generation development
- Experience with automated computer system and/or equipment software development
Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.
We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science.
Our recent $270 Million Series C brings our financing to over $500 million from investors, including; Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences.
Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure.
By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.
Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.
We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve. We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives. We believe in empowering and supporting each other in a collaborative and dynamic environment.
What does a successful person look like at Freenome?
Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.