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
BS degree, in a life sciences/scientific/engineering or quality management curriculum or equivalent experience. Master’s degree preferred
Experience in the development and implementation of effective Design Control Systems and in depth knowledge of IVDs regulations required
A minimum of 5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices, Quality management systems, and ISO 14971 Medical Devices required
Experience on applying risk management processes to medical devices required
Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint)
Demonstrated experience organizing and maintaining large documentation sets
Ability to follow up with task owners to close out open items
Familiarity with structured phase-gate product development processes
Effective verbal and written communication skills
Experience collaborating and communicate with individuals at multiple levels
Ability to organize and judge priorities
Ability to generate and maintain accurate records
Able to work effectively in a high-intensity, high-energy environment
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.
Employer will assist with relocation costs.
Additional Salary Information: Personalis offers a competitive compensation package that includes Base, Bonus and Options
Internal Number: 42
About Personalis Inc.
Personalis, Inc., is a dynamic venture-backed company founded out of Stanford pioneering precision medicine by developing, cutting-edge NGS genomic solutions for immuno-oncology, cancer, and inherited disease. Based in Menlo Park, CA, Personalis' patented ACE platform (Accuracy and Content Enhanced) provides an integrated, innovative, high accuracy technological solution from NGS sequencing to interpretation for precision medicine applications. The ACE Platform forms the technological basis for enabling Personalis' leading products for immuno-oncology, cancer diagnostics, and inherited disease.