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Supplier Quality Engineer

Job in Minneapolis, Hennepin County, Minnesota, 55400, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-06-26
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 70000 - 90000 USD Yearly USD 70000.00 90000.00 YEAR
Job Description & How to Apply Below

Overview

We are seeking a Supplier Quality Engineer to support supplier transfer activities and ensure compliance with quality and regulatory standards. The role involves validation execution, supplier quality management, and driving continuous improvement initiatives.

Roles & Responsibilities
  • Lead supplier transfer and qualification activities
  • Execute validations (IQ/OQ/PQ)
  • Manage quality agreements with suppliers
  • Handle Client/CAPA investigations and resolutions
  • Conduct supplier audits and ensure compliance
  • Perform risk management activities (FMEA, risk assessments)
Experience
  • Experience in supplier quality within medical device or regulated industry
  • Strong knowledge of IQ/OQ/PQ validations
  • Hands-on experience with Client/CAPA and audits
  • Familiarity with risk management processes
  • Ability to work onsite and start immediately.
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