Genomic Health, the world's leading provider of genomic-based cancer diagnostic tests, is seeking a Senior Quality Engineer to join the Quality Assurance team. This individual will collaborate closely with Clinical Laboratory Operations, Engineering, Reagent Manufacturing and Quality, Supply Chain Management, R&D, IT, and other functional areas, creating and continuously improving scalable and effective systems for ensuring consistent product quality and regulatory compliance. The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the design and ongoing application of these quality systems within the evolving regulatory landscape for Laboratory Developed Tests (LDTs) in the US, Europe, and elsewhere. He or she will participate in or lead deployment of Quality Management System (QMS) software modules, and will author, maintain, and measure compliance with quality system procedures and processes. This will include monitoring of key performance indicators and quality metrics, and close collaboration with other departments to ensure that quality related investigations and the associated corrective and preventive actions are complete and effective.
The position will report to the Associate Director of Clinical Laboratory Quality.
- Contribute to the ongoing development and continuous improvement of Genomic Health's quality management system, authoring and revising quality-related procedures, processes, and QMS software functionality to maximize effectiveness and scalability.
- Apply these quality system tools to facilitate consistent compliance with all applicable US and international quality regulations and quality standards (e.g. CLIA, NY, CAP, ISO 15189, ISO 13485, applicable FDA regulations, and others)
- Perform internal audits and assist with external inspections against these quality regulations and standards
- Facilitate and/or prepare effective, well-documented risk assessments
- Investigate nonconformances and complaints, conduct root cause analysis, and manage CAPAs
- Provide quality and regulatory guidance and support on cross-functional teams responsible for new product/service development, process improvements and troubleshooting activities in the Clinical Laboratory
- Participate on cross-functional teams responsible for securing and maintaining CLIA certification, CAP accreditation, ISO 15189 accreditation, ISO 13485 certification, NY laboratory regulations and state licensure activities.
- Assist with training of Quality Assurance and Clinical Laboratory Operations staff on new/revised policies and procedures and on the evolving regulatory landscape for Laboratory Developed Tests.
- Maintain quality records, analyze data, report quality metrics, make recommendations to laboratory management, and participate in the quarterly quality assurance and improvement committee meeting as well as the corporate quality management review.
- Other responsibilities as assigned
- BA/BS in Biomedical Laboratory Science, Molecular Biology, or related fields
- 8+ years of Quality experience in the life sciences industry preferably in a high-complexity CLIA clinical laboratory and/or FDA medical diagnostic regulated environment
- Working knowledge of CLIA/CAP/ISO15189/ISO 13485 standards and FDA QSRs in a regulated environment
- Demonstrated ability to lead and manage improvement projects
- Experience in continuous improvement of quality processes
- Excellent verbal and written communication
- Ability to work independently and to collaborate effectively in interdisciplinary teams
- Detail-oriented personality, strong organizational skills
- Ability to work as part of a team
- Direct experience with quality assurance in Clinical Laboratories developing and providing High-Complexity Laboratory Developed Tests
- Experience and working knowledge of current genomic and genetic testing methodology including quantitative PCR, DNA sequencing, and related technologies
- Experience and working knowledge of laboratory informatics software
- Experience conducting and supporting internal and external audits
- Certified Quality Auditor