Job details

Staff Quality Engineer, Device Quality (Reagent Manufacturing) # 3074

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.

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, Program Management, Clinical Affairs, 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.

Primary responsibilities include owning and facilitating NCRs, CAPAs, planned temporary deviations (DARs), equipment qualification and process validations, change management workflows, and acceptance activities including incoming and finished product release. This position additionally supports Quality Management Review (QMR), Quality Indices metrics generation and review, audits, and on-market Design History File and Risk Management File updates. As assigned, this role also supports the 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.

You will:

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.
Review and approve executed DHRs, QC workbooks and CoAs.
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.
Job level differentiation: demonstration of increasing technical proficiency; solving increasingly complex problems, and greater levels of independence in day to day activities.
Support Material Review Board (MRB) activities by owning and facilitating completion of timely and high quality Nonconformance reports (NCRs).
Support establishment, maintenance, and improvement of material specifications, including representing Quality Operations on the Material Review Committee (MRC) as applicable.
Support CAPA Review Board activities by owning and facilitating completion of timely and high quality CAPAs.
Support planned deviations under DAR workflows ensuring applicable regulatory requirements are fulfilled.
Facilitate equipment qualification, process validation, and test method validation for medical device production processes as well as related activities as assigned.
Complete impact assessments for proposed product and process changes as assigned.
Update post-design transfer Design History File/Risk Management File/Device Master Record/Medical Device File per assigned change management workflows.
Support generation and analysis of monthly Quality Indices reports as part of Measurement, Analysis, and Improvement activities, rolling up into QMR and QMI as applicable.
Support acceptance activities including incoming inspection and finished product inspection focusing on the RTP site and other activities as assigned.
Participate in preparation for and execution of internal and external audits and inspections. Support timely and compliant responses to observations.
Proactively identify improvement opportunities and collaboratively drive procedure and process changes as applicable.
Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.
Other duties as assigned.

Your background and qualification will include:

Bachelor’s degree in science, engineering, or other technical area.
Minimum of 8 years of experience working within a medical device, pharmaceutical, or biotech quality management system with 2 - 3 years of reagent manufacturing experience.
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.

Qualifications and experience (Preferred):

Master’s degree in a related technical area, or MBA.
Next Generation Sequencing (NGS) experience.
ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.
Clinical laboratory QMS experience (ISO 15189, CAP, CLIA, NYSDOH).

The expected, full-time, annual base pay scale for this position is $107,000 - 134,000. 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.

GRAIL Glassdoor Company Review

3.9