Quality Engineer - Manufacturing

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 manufacturing department.  In this role, the candidate will work closely with the manufacturing and supply chain organizations to ensure quality is an integral part of their process.  He/she is responsible for developing quality processes, plans and methodologies.  The Quality Engineer is responsible for driving continual product and process improvement for both NPI and Manufacturing activities. 

 Responsibilities:  
      
•    Lead the development of FMEAs for manufacturing teams to identify critical risks to be addressed. 
•    Establish and maintain quality plans to assure products will meet expectations of our target customers. 
•    Establish and maintain quality performance metrics
•    Support process capability analyses to investigate the ability of suppliers and production processes to meet defined specifications and quality standards. 
•    Audit manufacturing lines against released manufacturing processes and procedures.
•    Assist in the identification and resolution of manufacturing quality issues.  Manage and facilitate the root cause & corrective actions system through tracking and validation of issues. 
•    Manage nonconforming material through the MRB process to ensure that nonconforming material is identified, appropriately dispositioned, tracked, and reported.
•    Participate in supplier selection; audit suppliers when appropriate.
•    Participate in design reviews to assure product subsystem quality, reliability, etc.
•    Support manufacturing teams with process validation and equipment qualification.

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, ISO 14971 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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