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Senior Quality Analyst Medical Devices Salt Lake City, UT Hybrid

BURGEON IT SERVICES LLCSalt Lake City, UT🇺🇸United StatesPosted Oct 6, 2026

Quick Overview

Seniority
Mid Senior
Work mode
Hybrid
Location
Salt Lake City, UT, United States
Posted
21 hours ago

Job Description

Job Title: Senior Quality Analyst Medical Devices
Location: Salt Lake City, UT 84116 Hybrid Duration: 12 months plus
Experience: 6 12 years
Please send your updated resume to pranayatburgeonitsdotcom
Job Description
We are looking for a Senior Quality Engineer/Analyst with strong experience in Medical Device Quality Engineering and Manufacturing Quality. The candidate must be able to work independently with Quality, Manufacturing, and Operations teams in an FDA and ISO 13485 regulated environment.
Mandatory Skills
  • Medical Device Quality Engineering
  • Manufacturing Quality
  • FDA & ISO 13485 regulated manufacturing
  • Root Cause Analysis (RCA) & CAPA
  • SPC & Process Capability Analysis
  • PFMEA / Process FMEA
  • Control Plans
  • Plastics Manufacturing & Injection Molding
  • Assembly & Labeling Processes
  • Experience working independently with Quality, Manufacturing & Operations teams
  • Strong problem-solving, quality investigation, and documentation skills
Key Responsibilities
  • Perform quality engineering activities within regulated medical-device manufacturing.
  • Lead RCA, CAPA, and quality investigations.
  • Perform SPC and process capability analysis.
  • Support PFMEA, Control Plans, assembly, labeling, and injection molding processes.
  • Partner independently with Manufacturing, Quality, and Operations teams.

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