Software Validation Quality Engineer
- Employer
- Freenome
- Location
- South San Francisco, CA
- Start date
- Mar 23, 2022
View more
- Discipline
- Engineering, Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
About Freenome
Freenome is a high growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.
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
COVID safety:
As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy. If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster. If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Funding
We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures.
Freenomers
A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
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.
Benefits include but are not limited to:
- Competitive compensation
- Pre-IPO equity
- Flexible PTO (exempt) and generous PTO (non-exempt)
- Comprehensive health coverage, including medical, dental, and vision
- Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
- 401(k) plan
- $250.00 new hire stipend to enhance your home office experience
- Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts
Applicants have rights under Federal Employment Laws.
Notice to agencies:
Our in-house Talent Acquisition Team manages all employment opportunities at Freenome. Agencies and independent recruiters must be approved as a vendor by Freenome’s Talent Acquisition team before submitting candidates to any Freenome employee.
We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.
Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.
Company
Mission
Freenome is a high growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease.
Approach
To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.
Funding
We have raised more than $1.1B from leading investors including Andreessen Horowitz, Bain Capital, GV, Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Novartis, Verily, and more.
Freenomers
A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
- Website
- http://www.freenome.com/
- Phone
- (650) 446-6630
- Location
-
279 East Grand Avenue
5th Floor
South San Francisco
California
94080
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert