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Senior Quality Analyst Medical Devices Salt Lake , UT Hybrid
Job in
Salt Lake City, Salt Lake County, Utah, 84193, USA
Listed on 2026-10-12
Listing for:
BURGEON IT SERVICES LLC
Full Time
position Listed on 2026-10-12
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
Job Title:
Senior Quality Analyst Medical Devices
Location:
Salt Lake City, UT 84116 Hybrid Duration: 12 months plus
Experience:
6 12 years
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 & 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
- 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.
Position Requirements
10+ Years
work experience
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