Software Quality Analyst/Engineer (Contract)

Menlo Park, CA, United States
Jun 01, 2021
Quality, Quality Control
Biotech Bay
Required Education
Bachelors Degree
Position Type
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit

The Contract Software Quality Engineer plays an integral role in supporting quality activities in accordance with FDA, ISO and other IVD software regulations. As a member of the Software Quality team, this individual will support key initiatives to achieve GRAIL's software quality goals.

You will:

• Provide mentorship in Software Quality Engineering principles and Quality concepts in the following areas:
• Design Control
• Quality Improvement
• Risk Management
• Cybersecurity
• 21 CFR Part 11
• Develop Software Quality SOPs, Work Instructions, Templates
• Support new and existing off-the-shelf (OTS) projects through assessment and validation support
• Collaborate with software development teams, provide quality support, and facilitate the successful execution of the software Design Control process
• Support Design Verification and Validation activities, including review of requirements, traceability matrix, test plans and reports
• Assist with Quality documentation organization through eQMS transition
• Facilitate technical mentorship and training on quality assurance requirements, processes and procedures
• Act independently to determine methods and procedures on new assignment

Your background should include:

• A minimum of BA/BS with 3+ years of Quality Engineering experience in an FDA regulated medical device environment
• Proficiency at writing SOPs and Quality documentation
• Advanced knowledge of medical device development life cycles and Design Control processes
• Knowledge of FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, ISO 62304 and ISO 14971
• Ability to handle complex issues and exercise judgement, based on experience, with minimal mentorship from manager
• Software design and life cycle development experience/knowledge required
• Ability to plan and manage own work
• An aptitude for learning new platforms and technologies

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .