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Senior Medical Device Quality Engineer

Galaxy i Technologies, Inc.Salt Lake City, UT🇺🇸United StatesPosted Oct 6, 2026

Quick Overview

Seniority
Mid Senior
Work mode
Hybrid
Location
Salt Lake City, UT, United States
Posted
Yesterday

Job Description

Senior Medical Device Quality Engineer
Contract
Salt Lake City, UT 84116

Job Description:

Must have skills:
  1. Medical devices
  2. Medical Device Quality Engineering
  3. Manufacturing Quality
  4. Root Cause Analysis and CAPA
  5. SPC / Process Capability Analysis
  6. PFMEA and Control Plans
  7. Plastics Manufacturing and Injection Molding
  8. Assembly and Labeling Processes
  9. FDA and ISO 13485 regulated manufacturing environments
  10. capable of operating independently with quality, manufacturing, and operations teams
Detailed Job Description:
  1. Medical Device Quality Engineering
  2. Manufacturing Quality
  3. Root Cause Analysis and CAPA
  4. SPC / Process Capability Analysis
  5. PFMEA and Control Plans
  6. Plastics Manufacturing and Injection Molding
  7. Assembly and Labeling Processes
  8. FDA and ISO 13485 regulated manufacturing environments
The customer is specifically looking for senior-level engineers capable of operating independently with quality, manufacturing, and operations teams.
Minimum years of experience: 6-12 yrs
Education: Bachelor’s / Masters
The top 3 responsibilities would expect the Subcon to shoulder and execute:
FDA and ISO 13485 regulated manufacturing environments
Root Cause Analysis and CAPA
Medical Device Quality Engineering

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