Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The Senior Quality Engineer is an enthusiastic, self-motivated person with great communication skills who can support the Quality Management System through building and management of key infrastructure and direct support of laboratory operations in Flowslides and Sequencing. The Senior Quality Engineer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech start-up environment assisting in the implementation of a value added QMS based on CLIA/CAP, ISO 15189:2007, ISO 13485:2003 and FDA QSR regulations.
- Create, update, review, develop and execute standard operating procedures and supporting work instructions based in ISO 15189:2007, 13485:2007, FDA Quality System Regulations and CMS CLIA/CAP environments
- Direct and continuous involvement with development and operations to appropriate plan, facilitate and manage technology transfer and other projects
- Reduce process variation and increase process rigor throughout operations (focusing on Flowslides manufacturing and Sequencing) using quality tools, techniques and statistics
- Perform root cause data analysis, using statistical techniques and maintaining supporting databases for CAPA systems
- Create and maintain quality metrics as they relate to manufacturing processes and related activities for analysis and continual improvement
- Update, review, and develop Validation Program standard operating procedures and supporting work instructions based in ISO 13485:2003 and FDA Quality System Regulations
- Support training of personnel in requirements of quality tools and techniques, QMS based on CLIA/CAP, ISO 13485:2003/15189:2012, FDA 21 CFR 820 requirements
- Manage equipment preventive maintenance and calibration programs
- Review and approve equipment preventive maintenance and calibration records
- Any and all other undefined tasks, as directed by your supervisor
- Minimum, B.S./B.A. in Chemical Engineering, Molecular Biology, Chemistry or Life Science, Master’s preferred. 5+ years as a Quality/Process Engineer/Scientist or equivalent with part or all of it within a medical device or clinical laboratory environment
- Demonstrated knowledge of Risk Assessment tools, Quality Statistics, Reliability Engineering
- Ability to apply quality tools to develop new quality processes focused on process rigor and reduction in variation throughout operations
- Active participation in root cause analysis and process improvement using quality methodologies, DMAIC, SIPOC, etc.
- Basic understanding of Molecular Biology and Surface Chemistry as it pertains to DNA sequencing
-Experience in medical device / Biotech start-up/fast growth company or similar working environment
- Working knowledge of cGMP’s
- An understanding of Biochemistry as it pertains to DNA sequencing is required at a level to be able to create procedural documentation
- ASQ certification will be viewed favorably
- Experience in Clinical Laboratory regulated environments a plus
- A working knowledge of Six Sigma, Lean techniques and methodologies a plus
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Complete Genomics is a leader in accurate whole human genomic sequencing based in Mountain View, California. Our vision is to provide clinicians the genetic information needed to improve human health through prevention, diagnosis, and treatment of genetic diseases. Complete Genomics is focused on building a new generation of high-throughput sequencing technology and developing new and exciting research, clinical and consumer applications.
In March 2013, Complete Genomics was acquired by BGI-Shenzhen, the world’s largest genomics services company that provides comprehensive sequencing and bioinformatics services for commercial science, medical, agricultural and environmental applications. BGI is recognized globally as an innovator for conducting collaborative projects globally with leading research institutions. Additional information can be found at http://www.completegenomics.com.