Staff Quality Engineer # 2690
Menlo Park, CA, USA
Posted on Wednesday, May 3, 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 www.grail.com.
Primary responsibilities include facilitating NCRs, CAPAs, planned deviations (DARs), and change management; Quality Management Review (QMR), Quality Indices metrics generation and review, and on-market Design History File and Risk Management File updates. As assigned, this role also supports clinical laboratory quality processes. This individual contributes to a positive environment of accountability and performance excellence. This individual represents Quality Operations during audits and inspections as well as on various project teams as determined by management. This position requires regular on-site presence at the discretion of management.
- Support Quality Engineering operations through 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, CAP/CLIA/NYSDOH, ISO 15189, 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 complex problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables.
- Exercise good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Act independently with regular oversight 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.
- Job level differentiation: demonstration of increasing technical proficiency; solving increasingly complex problems, and greater levels of independence in day to day activities.
Your qualifications and background will include:
- Qualifications and experience (Required): Bachelor’s degree in science, engineering, or other technical area.
- Minimum of 7 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.
- Experience supporting regulatory inspections/audits and responding to findings.
- Excellent written and verbal communication skills.
- Ability to comprehend and interpret technical information.
- Master’s degree in a related technical area, or MBA preferred
- Next Generation Sequencing (NGS) experience preferred
- ASQ Certified Quality Auditor, Certified Quality Engineer, or similar preferred
- Clinical laboratory QMS experience (ISO 15189, CAP, CLIA, NYSDOH) preferred
The expected, full-time, annual base pay scale for this position is $123000 - $163,000. 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.