Genomic Health, the world's leading provider of genomic-based cancer diagnostic tests, is seeking a Design Control Quality 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 of new Genomic Health products/services. The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the area of product design control processes as they relate to Laboratory Developed Tests (LDTs) and in vitro diagnostics in the US, Europe, and elsewhere. He or she 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.
- Contribute to the development and ongoing continuous improvement of Genomic Health's Design Control process, authoring and revising design control-related procedures, processes, and QMS software functionality to maximize effectiveness and scalability.
- Contribute to 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 Risk Management process for new product/service development projects, collaborating with other project team members and other stakeholders to conduct risk analyses and ensure the appropriate implementation of risk mitigations.
- 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.
- 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 to management.
- Audit the DHF at each stage of the Design Control process.
- Other responsibilities as assigned
- BA/BS in Molecular Biology, Biomedical Engineering or related fields
- 5 plus years of Quality experience in the life sciences industry preferably in a FDA-regulated medical device, in vitro diagnostic, or other regulated environment
- Working knowledge of, and direct experience with 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 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
- 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 and working knowledge of software development life cycle best practices in a medical device and/or in vitro diagnostic environment
- Experience conducting and supporting internal and external audits
- Certified Quality Engineer