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