GRAIL
Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790
Durham, NC · Full-time
Sponsorship not specified$82k-$102kDetected 69 days ago
Data ScienceSupply ChainClinical TrialsClinical Laboratory TechniquesFDA RegulatoryNGSMedical DevicesResearchLeadershipCommunicationCollaborationCritical ThinkingMentoringRegulatory Affairs
About the role
- 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.
- This role's focus is on GRAIL's clinical laboratories, supporting the medical device processes as needed with consideration for the single GRAIL quality management system.
Responsibilities
- Leads and contributes to achieve company goals in creative and effective ways.
- Support monthly Quality Indices reports and quarterly Quality Monitoring and Improvement (QMI) Reviews.
- Perform risk assessments and work with leadership to create action plans to mitigate laboratory risks.
- Support maintenance and improvement of the QMS, including ensuring the system is efficient and compliant, through identification and monitoring of key performance indicators.
Requirements
- Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements.
Nice to have
- Master's degree in a related technical area, or MBA.
- Next Generation Sequencing (NGS) experience.
- ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.
- Physical Demands and Work Environment
- Work is performed in office, laboratory, and manufacturing environments.
- Regular interaction with production floor operations for quality reviews and troubleshooting.
- Use of precision measurement and inspection equipment as needed.
- Potential exposure to manufacturing noise, equipment, and regulated materials.
Compensation
- The expected, full-time, annual base pay scale for this position is $82,000 - $102,000.
This listing is sourced directly from GRAIL's careers page and normalized into a canonical job model.