Guardant Health is a pioneer in non-invasive cancer diagnostics & the first company tocommercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate & precise picture of the individual genomic alterations that cause tumors to grow, change, & develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, & our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development & improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish & new uses of our platform are emerging.
We succeed best by coordinating our creative talents & energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.
The Senior/Staff Software Quality Engineer (Design Control) plays an integral role in the implementation, support & continuous improvement of software quality management system (QMS) & software development life cycle (SDLC) framework, in accordance with FDA's Quality System Regulation (QSR), ISO 13485, CLIA/CAP & other applicable regulatory requirements, as well as best practices in the software industry.
- Primary point of contact for all software QMS & SDLC activities, providing guidance to Design Controls, Risk Management, & decisions to ensure continued compliance with internal procedures & applicable regulations
- Provide training, mentoring & compliance to the software, bioinformatics, IT & IVD product development, lab & clinical operations teams
- Develop solid understanding of various internal, external (partner, customer) & regulatory requirements, & provide expert guidance to software compliance/design controls, as applied to IVDs, medical devices, LDTs/CLIA/CAP, pharma & GxP (GCP, GCLP) environments
- Ensure required documentation & deliverables(e.g. DHF) are generated & maintained throughout SDLC, including but not limited to: SRS, SAD, SDS, V&V, trace-ability, risk management/FMEA & cyber-security
- Lead risk management & cyber-security related activities & documentation
- Assist with CSV (Computer System Validation) including 21 CFR Part 11
- Support compliance to various QMS policies, procedures & activities including but not limited to: CAPAs, internal & external audits, management reviews, document & change control, training, quality metrics
- Performs other related duties & responsibilities as assigned
- Bachelor's degree in Computer Science, Software Engineering, Informatics, Engineering, Biomedical or related field required
- 10+ years of software design assurance or relevant experience in an FDA/ISO regulated environment (medical devices/IVDs)
- Experience & working knowledge of applicable regulations & standards: 21CFR 820, 21CFR Part 11, ISO 13485, IEC 62304, ISO 14971, GAMP5
- Expertise in SDLC & experience with state-of-the-art SDLC tools
- Experience working in an Agile/Scrum teams
- Ability to operate flexibly, balance & prioritize multiple ongoing projects/tasks, in a fast-paced environment
- Able to deliver high quality results under minimal supervision
- Excellent problem-solving & analytical skills
- Effective communication & inter-personal skills
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.
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 & will not be discriminated against on the basis of disability.
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