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Job

Senior Quality Engineer

  • Job ref:

    8668

  • Location:

    Waltham, United States

  • Sector:

    Quality Engineers

  • Contact:

    Lissa Jerez

  • Published:

    9 months ago

  • Consultant:

    #

Responsibilities

  • Interaction with both suppliers and customers on quality problems 
  • Collection and analysis of  data from both within the factory and in the field
  • Risk assessment
  • Validation activities – creating and reporting IQ/OQ/PQ
  • Internal and Supplier audits and assessments
  • Supervision of the activities of two incoming inspectors
  • Management of the CAPA process
  • QMS training and maintenance of training records

Requirements

  • BS Mechanical, Electrical, Chemical Engineering or similar field
  • 10 + years of manufacturing and/or quality experience, preferably in the medical industry
  • Experience with ISO 13485 60601.
  • Strong statistical background.  Fundamental understanding of sampling plans & AQLs
  • Successful writing and reporting of IQ/OQ/PQ validations