Quality Engineer - R&D

Organization
Pacific Biosciences
Job Location
1380 Willow Road
Menlo Park, CA 94025
Job Description

Pacific Biosciences is looking for a Quality Engineer to support new Product Development.  He/she is responsible for developing quality processes and methodologies: working closely with the R&D staff to ensure quality is an integral part of their design control process.  The Quality Engineer is responsible for driving continual product and process improvement and to provide compliance guidance. 

 Responsibilities:         
•    Guide and support new product development with SW Development Lifecycle
•    Guide the product development team on product Verification & Validation
•    Implement Change Control process, represent quality on the change review board
•    Review the product requirements for compliance
•    Work with R&D on all elements of Design Control.  Participate in design reviews to assure product subsystem quality, reliability, etc. 
•    Audit R&D against released design control processes and procedures
•    Establish and maintain quality plans, to assure products will meet expectations of our target customers. 
•    Establish and maintain quality performance metrics
•    Assist in the identification and resolution of quality issues.  Manage and facilitate the root cause & corrective actions system through tracking and validation of issues. 

Requirements

•    4 year Technical Degree, a BSME is preferred
•    7-10 years of quality systems experience
•    Experience with DNA sequencing technologies
•    Expert with Software Development Life Cycle implementation in compliance with IEC 62304 
•    Experience with ISO13485 and 21 CFR Part 820 (Design Control)
•    Experience with 510k filing
•    Experience with ISO14971, FMEA, and IEC 62366
•    Knowledge of Life Science/Biotech industry regulations (FDA, GMP/QSR) practices 
•    Applicants must possess strong written and verbal communication skills 
•    Experience in a Life Science/Biotech company that has both an instrument and consumable products a plus

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

About Our Organization

Pacific Biosciences’ mission is to transform the way humankind acquires, processes and interprets data from living systems through the design, development and commercialization of innovative tools for biological research. The company has developed a novel approach to studying the synthesis and regulation of DNA, RNA and protein. Combining recent advances in nanofabrication, biochemistry, molecular biology, surface chemistry and optics, Pacific Biosciences has created a powerful technology platform called single molecule, real-time, or SMRT™, technology. SMRT technology enables real-time analysis of biomolecules with single molecule resolution, which has the potential to transform the understanding of biological systems by providing a window into these systems that has not previously been open for scientific study. 

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