Senior Quality Analyst Medical Devices Salt Lake City, UT Hybrid

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.