Quality Engineer 2, Device Quality Operations # 4376 at GRAIL

Durham, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, Medical DevicesIndustries

Requirements

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 (e.g., ISO 13485, ISO 14971, 21 CFR 820, IVDR)

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
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

Skills

Key technologies and capabilities for this role

QMSQuality Management SystemQuality EngineeringMedical DevicesIVD ProcessesClinical Laboratory OperationsRegulatory AffairsCompliance

Questions & Answers

Common questions about this position

Is this position remote or does it require on-site work?

This position requires regular on-site presence 5 days a week.

What salary or compensation is offered for this Quality Engineer role?

This information is not specified in the job description.

What key skills are required for this Quality Engineer position?

The role requires expert knowledge of quality engineering concepts including ISO 13485, ISO 14971, 21 CFR 820, and IVDR, along with critical thinking, problem-solving, independent judgment, and effective communication.

What is the company culture like at GRAIL?

GRAIL fosters a multi-disciplinary environment of scientists, engineers, and physicians focused on collaboration across departments like Quality, Clinical Laboratory Operations, Regulatory Affairs, and R&D to advance early cancer detection.

What makes a strong candidate for this Quality Engineer role?

Strong candidates demonstrate technical proficiency in quality engineering for medical devices, proactive creative problem-solving, ability to solve complex problems independently with excellent judgment, and effective communication with management.

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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