Senior Quality Assurance Engineer (LDT / IVD)

2 months ago(10/16/2017 5:15 PM)
Job ID
2017-5098
US
Category
Laboratory Operations
CA
Redwood City

Overview

Senior Quality Assurance Engineer

 

Genomic Health, the world’s leading provider of genomic-based cancer diagnostic tests, is seeking a Senior Quality Assurance 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 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.  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.

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

Qualifications

Required:

  • 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  

 

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

Travel, Physical/Mental Demands and Work Environment

    Travel Requirements : 0 - 10%
 
    Work Environment: 
- Standing or sitting for long periods of time may be necessary
- Some lifting (greater than 25 pounds) may be necessary
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation
- Repetitive manual pipetting is necessary

Company Profile

Genomic Health is a global provider of genomic-based diagnostic tests that address the overtreatment of cancer, one of the greatest issues in healthcare today. Our goal is to improve the lives of people with cancer by providing personalized, biological information that helps them get the right treatment at the right time, and to avoid unnecessary treatments and their side effects. In this way, our work is truly life, changing.

 

  • Our Oncotype IQ Genomic Intelligence Platform is a portfolio of diagnostic tests that help physicians and patients answer specific and critical treatment questions throughout the cancer journey
  • We currently offer Oncotype tests addressing breast, colon, prostate and lung cancers and hundreds of thousands of patients from over 90 countries have benefited from our tests.
  • The Oncotype DX breast cancer test is considered standard of care in the US and is included in all major international clinical guidelines for breast cancer treatment.
  • We are expanding our portfolio of tests to include additional liquid- and tissue-based tests through clinical research and internal product development as well as strategic partnerships.

 

Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential.  We embrace our unique culture characterized by our Core Values of Community, Truth Seeking, Being Ahead of the Curve and Winning to be the best in the world at what we do. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs. 

 

All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.

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