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Katalyst HealthCares & Life Sciences
Quality EngineerKatalyst HealthCares & Life Sciences • Bloomingdale, IL
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Quality Engineer

Quality Engineer

Katalyst HealthCares & Life Sciences • Bloomingdale, IL
30+ days ago
Job type
  • Full-time
Job description


Roles & Responsibilities:

  • Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
  • Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
  • May lead or verify effectiveness of corrective and preventive actions (CAPAs).
  • Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
  • Responsible to create, implement and improve quality systems and procedures for meeting ISO , FDA and customer quality system requirements.


Education & Experience:

  • We need someone with technical experience with GD&T and knowledge of blueprint reading and being able to describe the symbols on a blueprint and what the symbols mean.
  • Bachelor's Degree in Engineering or related field is preferred
  • CAPA, Root Cause Analysis
  • Med device and Manufacturing experience is preferred
  • - years' experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T. Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulation

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Quality Engineer • Bloomingdale, IL

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