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Quality Engineer

Job in Carol Stream, DuPage County, Illinois, 60158, USA
Listing for: Fusion Life Sciences
Full Time position
Listed on 2026-01-13
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
  • Engineering
    Quality Engineering, Process Engineer
Job Description & How to Apply Below

Job Title:
Quality Engineer

Location:

Carol Stream, IL
Length: 6 months

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 for creating, implementing and improving quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements.
Qualifications
  • Bachelor’s Degree in Engineering or related field is preferred
  • CAPA, Root Cause Analysis
  • Med device and Manufacturing experience is preferred
  • 0-3 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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