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. As the Senior Quality Assurance Engineer, you will collaborate closely with Operations, Development, Supply Chain, Engineering, IT, Regulatory, and other functional areas on the development and commercialization of Genomic Health products/services. To be successful, you will have the expertise, creativity, and communication skills to provide leadership in the areas of product/service, risk management, design control, change control and validation as they relate to medical device products and clinical services in the US, Europe, and elsewhere. Additionally, you will be the program administrator for risk management and change control and may be a member of product development teams representing Quality and, ultimately, the customer. This includes ensuring that Genomic Health product processes are appropriately applied and followed throughout the product/service life-cycle.
The position will report to the Senior Director of Quality Assurance.
- 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
- Lead the effective, efficient, and compliant development of new products and
services and changes to commercialized products/services as the Quality
Assurance representative on the associated cross-functional 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
- Partner with cross-functional teams to determine the appropriate level of
verification and validation required for changes in product processes, methods,
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
- Author the Quality Plan for product/service development projects and process
improvement projects, and manage the plan throughout the development
- Maintain quality records, analyze data, report quality metrics, and make process
improvement recommendations to management.
Participate in cross-functional teams responsible for securing and maintaining
CLIA certification, CAP and, ISO 15189 accreditation, ISO 13485 certification, NY
laboratory regulations, and state licensure activities.
- Other responsibilities as assigned
- 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
- 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
- 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
- Experience conducting and supporting quality audits
Certified Quality Engineer
• Travel Requirements: 0-10%
• Standing or sitting for long periods of time may be necessary
• Some lifting (greater than 25 pounds) may be necessary.
• A considerable amount of time using various types of laboratory equipment including microscopes, microtomes, blades, strainers, pipettes
• May perform repetitious actions using lab tools
• Some time spent using near vision to view samples at close range
• Use of various chemicals may be used to perform duties
• At times, stress may be experienced
• Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation