Senior Quality Assurance Engineer (LDT / IVD)

Organization
Genomic Health
Job Location
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Redwood City, CA 94063
Job Description

 

 

Genomic Health, the world's leading provider of genomic-based cancer diagnostic tests, is seeking a Quality Assurance Project Manager 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 to Laboratory Developed Tests (LDTs) and in vitro diagnostics in the US, Europe, and elsewhere. As the Quality Assurance Project Manager, 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.

Responsibilities

  • 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 to management.
  • 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



Requirements

 

 

Required:

  • BA/BS in Molecular Biology, Biomedical Engineering or related fields
  • 8 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

 

Desired:

  • 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



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PI100148033

How to Apply

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