Sr. Design Control Quality Engineer

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.

Position Summary:

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 medical devices. 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.

Responsibilities:

  • Responsible for Design Control initiatives to develop appropriate Design History File documents and drive the Design Control Quality sub-system
  • 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

Education / Experience

  • BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master’s degree preferred
  • 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
  • Experience in the development and implementation of effective Design Control Systems
  • Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices
  • Working knowledge of EN 60601, Safety requirements for medical electrical systems
  • Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process and AAMI TIR 45 implementation
  • 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

Skills / Competencies:

  • 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