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GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
The Role
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the bay area of California, 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 grail.com
This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL’s quality management system (QMS). This role’s focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes as needed with consideration for the single GRAIL QMS. This position interacts with departments throughout the organization including but not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, ProgramManagement, ClinicalAffairs, Supply Chain, Manufacturing, and Research &Development. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management.
This position requires regular on-site presence (5 days a week)
Responsibilities:
- Support medical device Quality Engineering operations through expert interpretation, establishment, and execution of quality engineering concepts and principles in accordance with GRAIL’s quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations and standards.
- Use proactive, creative problem-solving to contribute to development of concepts and principles to achieve goals and objectives.
- Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
- Solve extremely complex problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables.
- Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Act independently to determine methods and procedures to successfully complete assignments.
- Structure day-to-day work autonomously, effectively communicating status and issues with management.
- Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes.
- Support qualifications & validation activities (IQ/OQ/PQ/TMV)
- Support DHR review process
- Support NCR, DAR & CAPA process
- Support change management workflows, and acceptance activities including incoming and finished product release.
- Support Quality Management Review (QMR), Quality Indices metrics generation and review, audits, and on-market Design History File and Risk Management File updates.
- Support audits and inspections as needed
- Support other project teams (including clinical laboratory) as determined by management.
- These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.
Required Qualifications:
- Bachelor's degree in science, engineering, or other technical area.
- Minimum of 3 years of experience working within a medical device, pharmaceutical, or biotech quality management system.
- Experience working with in vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements.
- Strong written and verbal communication skills.
- Ability to comprehend and interpret technical information.
The expected, full-time, annual base pay scale for this position is $82K - $96K for NC. Actual base pay will consider skills, experience, and location.
This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.
GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.
GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!
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The Company
What We Do
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity 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 and commercialize pioneering products.
Why Work With Us
Everything we do is guided by our mission to detect cancer early, when it can be cured. It’s the reason we’re here, and it’s no small task.
The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge, contribute their skills, inspire each other and commit to something bigger than themselves.
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GRAIL Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
GRAIL has a variety of work types depending on the roles. Some are onsite like a lab role, others are hybrid and still others are remote. Hybrid is typically Tuesday and Thursday but leaders may be flexible depending on the role.
Typical time on-site:
2 days a week
