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Quality Engineer, Reagents

Pacific Biosciences


Location:
Menlo Park, CA 94025
Date:
05/17/2020
2020-05-172020-06-16
Categories:
  • Biotechnology / Science
  • Manufacturing / Production
  • Financial Services
  • Engineering
Pacific Biosciences
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Job Details

Pacific Biosciences is looking for a Quality Engineer to support the reagent product line.  He/she is responsible for developing quality processes and methodologies; working closely with the Manufacturing and R&D staff to ensure quality is an integral part of their processes.  The Quality Engineer is responsible for driving continual improvements and to provide compliance guidance.



Responsibilities:         



  • Represent the Quality Team on Core Teams

  • Support the Reagent development teams during development and product transfer

  • Support the development teams during Verification & Validation activities

  • Work with R&D on all elements of Design Control.

  • Support the reagent manufacturing teams on good manufacturing practices and process control

  • Support manufacturing and development teams with deviations, and product nonconformances

  • Support process validation activities

  • Support supplier qualification, audit and improvement projects

  • Establish and maintain quality plans and quality performance metrics

  • Assist in the identification and resolution of quality issues and complaints

  • Support field actions related to the reagent product line

  • Audit manufacturing and R&D against released design control processes and procedures



 


All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.




Position Requirements:         



  • 4 year Technical Degree, a BS degree in Molecular Biology (or a related field) is preferred

  • 7-10 years of quality systems experience

  • Strong understanding of reagent development for an IVD product

  • Expert knowledge of ISO 13485 and ISO 9001

  • Experience with ISO 14971, and Failure Mode and Effects Analysis

  • Applicants must possess strong written and verbal communication skills

  • Experience teaching quality concepts and demonstrating quality system value

  • Experience with DNA sequencing technologies or experience in a Life Science/Biotech company with a product that includes an instrument and consumables



 


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.
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