Quality Engineer 2, Device Quality Operations # 4376

Job description

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 Menlo Park, 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.

**Preferred Qualfications:**

+ Bachelor's degree in science, engineering, or other technical area.
+ Minimum of 5 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.

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 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 (https://grail.com/about/#contact-us) to request accommodation.

GRAIL maintains a drug-free workplace.

Required Skill Profession

Other General