Quality System Specialist

Pacific Biosciences
Job Location
Menlo Park, CA
Job Description

As the Quality System Specialist, you will develop, maintain and manage the quality system in compliance with ISO 13485 and QSR820. You will engage with managers and employees to ensure quality is a primary focus in all aspects of business operations.

Maintain the quality system in compliance with ISO 13485 and QSR 820
Manage Corrective Action and Preventive Action programs; make sure the CA/PA system is actively being used with results analyzed for effectiveness
Manage the calibration and preventive maintenance programs
Perform internal audits and develop team to perform audits
Assist with regulatory, customer, and registration audits
Oversee the complaints management process
Perform, and participate in supplier qualification audits. Work with the supply chain organization to ensure supplier performance meets our quality and strategic requirements
Oversee the training program
Ensure Quality objectives are measured and reviewed to ensure effectiveness
Prepare data and coordinate management reviews


M.S. degree in an engineering or in a scientific field
5 to 8 years of relevant experience working with medical device and/or in-vitro diagnostic.
In depth experience with ISO 13485 and QSR 820 for in vitro diagnostic
Practical experience with ISO 14971, IEC 62304, and IEC 62366
Experience managing CA/PA program
Experience building quality system from the ground up
Excellent communication skills with strong attention to details and ability to multi-task
Experience working with cross-functional teams
Practical experience with lean principles
Willingness to be hands-on with solid problem solving skills
ASQ certification preferred

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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