Staff Software Quality Engineer (Remote) #2694



Quality Assurance
United States · Remote
Posted on Thursday, April 13, 2023
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
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.

You will:

  • Provide Software Quality guidance for multiple IVD/CDx projects with focus on analytical software (bioinformatics pipeline and AI software ) to ensure compliance with GRAIL’s SDLC and QMS
  • Guide the Bioinformatics team through Software Configuration strategies Verification and Validation approach, Risk Management strategies
  • Support and provide guidance for regulatory submissions such as PMA, IDE, and pre-sub
  • Facilitate participation in strategic/technical discussions and risk-based decision making
  • Drive and coach software risk management activities in accordance with industry standards
  • Ensure quality and completeness of design history files for software
  • Develop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organization
  • Ensure SDLC processes meet quality and regulatory requirements and identify areas and opportunities to improve quality system processes
  • Support post market activities related to product software anomalies - Complaint Handling, MDR’s, CAPAsTrend, analyze, and report on quality data to improve product and process
  • Drives measures of accountability through process and motivation; leads by example and mentoring of junior engineers; influence individuals and departments to achieve quality

Your qualifications and background will include:

  • Extensive knowledge of product development, and specifically software development (SDLC) processes, Design Controls, Software Engineering Best Practices
  • Hands-on experience with analytical software (Artificial Intelligence, machine learning, bioinformatics pipeline or secondary/tertiary analysis) development in a programmer, tester, project management or related capacity
  • A minimum of BA/BS with 7 years’ experience in (software) quality engineering or related role in a medical device / IVD company environment
  • Working experience with relevant industry standards (FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
  • Experience with software maintenance activities (failure investigations/bug fixes)
  • Ability to operate flexibly in fast paced environment
  • Partners with other functions to drive a culture of Quality
  • Leverages strong technical subject matter expertise, experience, and personal influence to resolve wide range of highly complex issues in creative and effective ways
  • Ability to handle complex issues and exercise judgment, based on experience, with minimal guidance from managerFamiliarity with project collaboration tools, e.g., Confluence, Jira
  • An aptitude for learning new software platforms and technologiesExcellent interpersonal, verbal and written communication skills
  • Occasional travel may be required
The expected, full-time, annual base pay scale for this position is $107,000 - $142,000. Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
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. GRAIL maintains a drug-free workplace.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. 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 for consideration by GRAIL.