Personalis is a genome-scale diagnostics company pioneering genome-guided medicine. Personalis Genome Services provides clinicians and researchers accurate comprehensive end-to-end human genome sequencing and interpretation solutions in Cancer, Immune-oncology and Inherited Disease. We provide accuracy-enhanced genome sequencing assays, conducted in our state-of-the art laboratory. We analyze results utilizing proprietary databases, advanced human reference sequences, and sophisticated algorithms. Located in Menlo Park, CA, we are seeking a talented and highly motivated Sr. Quality Engineer to join our team.
This position is responsible for the development and implementation of Personalis Design Control system to ensure current products and new projects meet the regulatory and quality requirements for In Vitro Diagnostics (IVDs). Interfaces with other departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.
- Responsible for Design Control initiatives to develop appropriate Design History File documents and drive the Design Control Quality sub-system for IVDs
- Review and approve new product documentation, as required
- Collaborate with Project Management to optimize Design Control processes and develop Sustaining Quality Engineering processes
- Develop and approve Design Control documents and protocols
- Serve as the Design Control expert to organization
- Develop and deliver Design Control training for organization
- Drives Risk Management activities (ISO 14971) and ensure compliance to standards and regulations
- Performs other duties, as assigned