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Senior Quality Assurance Engineer II

Apply Share Job ID 1580 Category Quality Assurance/Regulatory Job Location Redwood City, CA, CA Posted Date 10/20/2019

Overview:

Genomic Health, the world's leading provider of genomic-based cancer diagnostic tests, is seeking a Senior Quality Engineer to join the Quality Assurance team. This individual will collaborate closely with Clinical Laboratory Operations, Engineering, Reagent Manufacturing and Quality, Supply Chain Management, R&D, IT, and other functional areas, creating and continuously improving scalable and effective systems for ensuring consistent product quality and regulatory compliance. The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the area of corrective and preventive action (CAPA) subsystems, such as Non-conforming product, CAPA, Deviations, Complaints and quality audits, as it relates to in-vitro diagnostic products and clinical laboratory testing services in the US, Europe, and elsewhere. The individual will lead implementation of improvements to these programs and support deployment of Quality Management System (QMS) software modules, and will author, maintain, and measure compliance with quality system procedures and processes. 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.

The position will report to the Manager of Quality Assurance or higher.

ESSENTIAL RESPONSIBILITIES / DUTIES:
· Investigate nonconformances and issues, conduct root cause analysis, and manage CAPAs
· Contribute to the ongoing development and continuous improvement of Genomic Health's quality management system (QMS), authoring and revising quality-related procedures, processes, and QMS software functionality to maximize effectiveness and scalability.
· Apply these quality system tools to facilitate consistent compliance with all applicable US and international quality regulations and quality standards (e.g. CLIA, NY, CAP, ISO 15189, ISO 13485, applicable FDA regulations, EU, Japan, and others)
· Provide quality guidance, support and leadership in the CAPA sub-system processes and other quality system processes such document control, training, batch record review and release for IVD products/services collaborating with other team members and stakeholders to evaluate established requirements and determine measures necessary for implementation of programs.
· Perform internal quality audits and assist with external inspections against these quality regulations and standards
· 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.
· Support and conduct training of Quality Assurance and cross-functional personnel on new/revised policies and procedures and on the evolving regulatory landscape for commercialized tests as well as new tests.
· Maintain quality records, analyze data, report quality metrics, make recommendations to laboratory management, and participate in the quarterly quality assurance and improvement committee meeting as well as the corporate quality management review.
NON-ESSENTIAL RESPONSIBILITIES / DUTIES:
· Other responsibilities as assigned
TRAVEL/PHYSICAL/MENTAL REQUIREMENTS
· Several hours per day spent using computer and related systems
· Considerable time spent performing focused analysis and some writing
· Some time spent communicating verbally through phone, email and in person
· Some stress may be experienced
· Little to no travel
· Lifting/pushing/pulling up to 25 pounds occasionally

QUALIFICATIONS:

REQUIRED
· BA/BS in Molecular Biology, Biomedical Engineering, Clinical Laboratory Science or related field
· 8+ years of Quality experience in the life sciences industry preferably in a high-complexity CLIA clinical laboratory and/or FDA medical diagnostic regulated environment
· Working knowledge of CLIA/CAP/ISO15189/ISO 13485 standards and FDA QSRs in a regulated environment from concept to commercialization
· Demonstrated ability to lead and manage CAPA sub-systems processes, including risk management activities and improvement projects
· 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
· Ability to work as part of a team
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 and working knowledge of laboratory informatics software
· Experience conducting and supporting quality audits (internal, supplier, third-party)
· Certified Quality Auditor
· Certified Quality Engineer

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The successful candidate will have the expertise, creativity, and communication skills to provide leadership in the area of corrective and preventive action (CAPA) subsystems, such as Non-conforming product, CAPA, Deviations, Complaints and quality audits, as it relates to in-vitro diagnostic products and clinical laboratory testing services in the US, Europe, and elsewhere.
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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!