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.

The Senior Staff Software Quality Engineer (SQE) is the domain expert in medical device software regulations and software development methodologies in support of GRAIL’s new and commercialized products. As a project Quality lead, the Sr Staff SQE will work closely with multi-functional teams to provide software quality guidance in software IVD regulations and design control compliance.

You will:

• 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 in application development.
• Lead Software Quality project activities associated with software design control and related regulatory compliance activities for GRAIL developed software.
• Collaborate with multi-functional project teams to provide software quality expertise and facilitate the successful execution of the design control procedures and software releases.
• Provide input into SOPs, templates, work instructions and relevant documents to support software projects and GRAIL’s QMS.
• Responsible for timely completion and approval of SQE deliverables, e.g., hazard analysis.
• Support Design Verification and Validation activities, including review of plans, protocols and reports.
• Work closely with Project and Product Managers in the analysis of product requirements and specifications.
• Participate in product design reviews and meetings.
• Provide support of QMS teams such as Corrective and Preventive Actions (CAPA), supplier corrective actions, and document control.
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Enforce and implement standards and compliance with results-based key performance indicators, root cause analysis and defect prevention techniques, test standards and reports.
• Provide technical guidance and training as needed on software regulations.

Your qualifications and background will include:

• A minimum of BA/BS with 5+ years of Quality Engineering experience in a regulated medical device manufacturing environment.
• Advanced knowledge of, and 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.
• Proven experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.
• Familiarity with project collaboration tools, e.g., Confluence, Jira.
• An interest in learning new software platforms and technologies.
• Proven SW Development Life Cycle (SDLC) background and experience, familiarity and direct experience with Agile development methodologies and Continuous Integration and Continuous Deployment (CI/CD).
• Ability to handle complex issues and exercise judgment, based on experience, with minimal mentorship from a manager.
• Acknowledged by others as proactive, engaging, and collaborative.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.