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Grail
Grail

Biotechnology company.

Staff Quality Engineer, CAPA Program #4693

직무QA
경력Staff+
위치Durham, New Caledonia, United States
근무오피스 출근
고용정규직
게시1개월 전
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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

Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Staff Quality Engineer is responsible for leading, executing, maintaining, and improving the Corrective and Preventive Action (CAPA) program in accordance with ISO 13485:2016 and 21 CFR Part 820, Quality Management System Regulation. This role additionally supports the Nonconformance (NCR) program, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), Quality Indices (QI), Change Control, Quality Planning, clinical laboratory licensure/certification, internal and external audits, and other activities as assigned. This person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. 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 role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.

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Grail 소개

Grail

Grail

Series C

GRAIL, Inc. is an American biotechnology company based in Menlo Park, California founded in 2015 seeking to develop an early cancer screening test for people who do not have symptoms. As a startup it was a subsidiary of Illumina, which bought it outright in 2021.

201-500

직원 수

Menlo Park

본사 위치

$3.2B

기업 가치

리뷰

10개 리뷰

3.9

10개 리뷰

워라밸

3.8

보상

3.5

문화

4.2

커리어

3.0

경영진

3.2

72%

지인 추천률

장점

Good work-life balance

Supportive team and management

Innovative and challenging projects

단점

Heavy workload and overwhelming at times

Limited career advancement opportunities

Management and communication issues

연봉 정보

135개 데이터

Senior/L5

Senior/L5 · Senior Analytical Engineer

3개 리포트

$187,544

총 연봉

기본급

$163,039

주식

-

보너스

-

$180,790

$195,500

면접 후기

후기 4개

난이도

2.8

/ 5

소요 기간

14-28주

경험

긍정 25%

보통 75%

부정 0%

면접 과정

1

Application Review

2

Recruiter Screen

3

Technical Phone Screen

4

Onsite/Virtual Interviews

5

Team Matching

6

Offer

자주 나오는 질문

Technical Knowledge

Behavioral/STAR

Past Experience

Coding/Algorithm