Job ID 894
Genomic Health, the world's leading provider of genomic-based cancer diagnostic tests, is seeking a Senior Quality Assurance Engineer to join the Quality Assurance team. This individual will collaborate closely with R&D, Supply Chain, Engineering, IT, Regulatory, and other functional areas on the development and commercialization of Genomic Health products/services. The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the areas of product design control, risk management, change control and validation as they relate toLaboratory Developed Tests (LDTs) and in vitro diagnostics in the US, Europe, and elsewhere. As the Senior Quality Assurance Engineer, you will be an active member of product development teams representing Quality and, ultimately, the customer. This will include ensuring the Genomic Health product development processes are appropriately applied and followed throughout the product/service development process.
The position will report to the Senior Director of Quality Assurance.
Lead the development and ongoing continuous improvement of Genomic Health's Quality Management System (QMS), authoring and revising related procedures, processes, and QMS software functionality to maximize effectiveness and scalability.
Lead the effective, efficient, and compliant development of new products and services as the Quality Assurance representative on the associated cross-functional development teams.
Provide leadership in the Validation and Risk Management processes for new product/service development projects, collaborating with other project team members and other stakeholders to ensure the appropriate implementation of programs
Partner with R&D, Operations, and IT to determine the appropriate level of verification and validation required for changes in instrumentation, software, reagents, and lab processes.
Manage the change control process by monitoring all types of changes that can influence the process reliability and product quality. Evaluate the relevant established requirements and determine the measures necessary for implementing the change.
Author the Quality Plan for product/service development projects and process improvement projects, and manage the plan throughout the development process.
Maintain quality records, analyze data, report quality metrics, and make process improvement recommendations tomanagement.
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.
Other responsibilities as assigned
BA/BS in Molecular Biology, Biomedical Engineering or related fields
5 years of Quality experience in the life sciences industry preferably in an FDA-regulated medical device, in vitro diagnostic, or other regulated environments.
Working knowledge of, and direct experience with the application of the ISO 13485 standard and/or FDA QSRs to product and process development
A track record of success in the effective application of design control best practices to product and process development
Experience in software, instrument and reagent development and validation
Demonstrated ability to lead and manage risk analysis meetings
Experience in the continuous improvement of quality processes
Excellent verbal and written communication
Ability to work independently and to collaborate effectively with interdisciplinary teams
Detail-oriented personality, strong organizational skills
A strong desire and demonstrated ability to collaborate and lead effectively in a fast-paced, interdisciplinary team-oriented environment
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 conducting and supporting quality audits
Certified Quality Engineer
As the Senior QA Engineer, you will provide leadership in the areas of product design control, risk management, change control and validation as they relate to Laboratory Developed Tests (LDTs) and in vitro diagnostics in the US, Europe, and elsewhere. Being an active member of the product development team, you will be the representative for QA and ultimately the customer ensuring that all processes are appropriately applied and followed throughout the product/service development process.