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Senior Quality Assurance Engineer (Non-Conformances)

Apply Share Job ID 1045 Category Quality Assurance/Regulatory Job Location Redwood City, California Posted Date 07/21/2018


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 QA Engineer, you will collaborate closely with functional departments and cross-function teams such as Operations (Clinical Laboratory, Manufacturing/Quality, Supply Chain, Engineering), R&D, IT and other areas, creating and continuously improving scalable and effective systems for ensuring that product and services meet customer needs and quality, regulatory and accreditation compliance.

To be successful, you will have the expertise, creativity, and communication skills to provide leadership in the definition, implementation, and training of these quality systems. You will participate in or oversee Quality Management System (QMS) processes, and will author, maintain, and measure compliance with quality system policies and procedures. This will include monitoring of key performance indicators and quality metrics, and close collaboration with other departments to ensure that quality related investigations and the associated corrective and preventive actions are complete and effective. Familiarity with the clinical laboratory environment, diagnostic testing, laboratory information systems, laboratory regulatory and accreditation requirements, medical device quality system requirements and quality management system software. (CLIA, CAP, NY, ISO 15189, ISO 13485, IVDD/IVDR, FDA) is highly desired.

The broad scope and complex nature of the work requires excellent attention to detail, effective written and verbal communication skills, familiarity with and the ability to analyze complex issues across all quality processes and work both independently and in a dynamic, cross-functional team environment.

· Oversight and facilitation of the CAPA sub-system, including nonconformances, CAPA and complaints.
Conduct and review investigations, root cause analysis, risk assessments, action plans, objective
evidence and effectiveness checks.
· Develop and define quality metrics, analyze quality-related data, identify issues or trends and make
recommendations to management to ensure development, improvement and adequacy of the quality
management system, product and processes. Participate and/or lead quality meetings (e.g. quarterly
quality assurance and improvement committee meetings).
· Perform internal audits and assist with external inspections against laboratory and quality regulations and
standards, document findings, facilitate implementation and closure of corrective/preventive actions.
· Conduct QA document review including, but not limited to, protocols, reports, procedures and records (e.g.
batch record review).
· Contribute to the ongoing development and continuous improvement of Genomic Health's quality
management system, including authoring and revising quality-related policies, procedures and forms and
provide quality related training as needed for employees on new or revised processes or regulatory
· Prepare annual lab license renewals and accrediting agency renewals/applications, as appropriate.
· Participate and lead cross-functional teams responsible for securing and maintaining certifications (e.g.
CLIA, ISO 13485), accreditation (e.g. CAP, ISO 15189), State (e.g., NY, CA) laboratory regulations and state
licensure activities.
· Provide quality and regulatory guidance and support on cross-functional teams responsible for new and
revised products/services, process improvements and troubleshooting.
· Provide QA review of policies, procedures, protocols, reports and quality records as needed to support
products, services and the quality management system.
· Other responsibilities as assigned


· Bachelor of Science in Laboratory Science, Clinical Science, Life Science or related field
· At least five years of Quality experience in a regulated environment with experience in diagnostics or
medical devices
· Experience with internal audits, resolving non-conforming events or complaints
· External audits experience (facilitator or participant) by CAP, CLIA, ISO 15189 Accrediting Agency, ISO
13485, FDA or similar agency
· Ability to analyze and solve complex issues
· Strong computer skills and job and industry knowledge
· Excellent clear and consistent written and oral communication skills with the ability to effectively
communicate technical information to technical and non-technical audiences
· Ability to integrate and apply feedback in a professional manner
· Ability to work independently and to collaborate effectively in interdisciplinary teams
· Familiar with risk management, root cause analysis, and process improvement tools.

· Quality experience in a CLIA laboratory and/or FDA regulated organization.
· Certified Quality Auditor, ASQ certification or equivalent
· Experience and working knowledge of current genomic and genetic testing methodology including
quantitative PCR, DNA sequencing, and related technologies
· Advanced working knowledge of local, state, and federal laboratory/medical device regulations and
accrediting agency requirements (CLIA, CAP, CA, NY, ISO 15189, ISO 13485, IVDD/IVDR, FDA)
· Experience working with electronic quality management systems
· Experience implementing process or quality improvements projects
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!