GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
GRAIL is looking for a talented Staff Software Quality Engineer to be the subject matter expert and provide software quality guidance and support to our teams developing software applications and systems in support of GRAIL’s commercial product, Galleri, a multi-cancer early detection blood test, on-going clinical studies and new products in development.
- Provide subject expertise and input in the following areas: quality standards for software applications and systems that the company develops in support of the commercial product; quality processes, assessments and validations of third-party tools used for application development or in the application.
- Support Software Quality activities associated with software design control, design review and related regulatory compliance activities.
- Collaborate with software development teams, provide quality support, and facilitate the successful execution of the Software Design Control Process and software releases.
- Facilitate identification of product risks and risk mitigations for software development and change controls.
- Resolve complex issues in creative and effective ways using professional Quality Management concepts in line with company objectives.
- Provide input into software development and risk management policies.
- Support Design Verification and Validation activities, including review of verification & validation protocols and reports.
- Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
- Ensure compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
- Support internal/supplier, partner audits and regulatory inspections of quality management functions, processes, and procedures with regards to software.
- Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated.
- Trend, analyze, and report on quality data in order to improve product and process.Support SW supplier qualification activities.
Your qualifications and Experience will include:
- A minimum of BA/BS with 5+ years of Quality Engineering experience, ideally in vitro diagnostics / medical device or other regulated industry
- Proficiency with medical device software development life cycles (SDLC) and Design Control processes
- Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304
- Knowledge of 21CFR Part 11 and Computer System Validation documentation, compliance and maintenance
- Ability to handle complex issues and exercise judgment, based on experience, with minimal guidance from manager
- Familiarity with project collaboration tools, e.g., Confluence, Jira
- Ability to plan and execute Software QA activities
- An aptitude for learning new software platforms and technologies
- Excellent interpersonal, verbal and written communication skills