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 the R&D department.  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:         

•    Lead the product risk assessment effort. 
•    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.
•    Work with R&D to determine product specifications and tolerances.  Participate in design reviews to assure product subsystem quality, reliability, etc. 
•    Support process capability analyses to investigate the ability of suppliers and production processes to meet defined specifications and quality standards. 
•    Audit R&D against released design control processes and procedures 
•    Support R&D with human factor\usability requirements
•    Support R&D with SW Development Lifecycle

Requirements

•    4 year Technical Degree, a BSME is preferred, 
•    7-10 years of quality systems experience in a manufacturing environment. 
•    Experience with ISO13485 and 21 CFR Part 820 required
•    Experience with ISO14971, FMEA, IEC 62366 and IEC 62304 required
•    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

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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