Quality Engineer, MedTech | ISO 13485 & CAPA
Listed on 2026-10-06
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Nuwellis, Inc. is seeking a Quality Engineer to strengthen our Quality Management System and ensure our medical-device products meet QMSR, ISO 13485, and applicable regulatory requirements.
You will collaborate with Engineering, Manufacturing, Supplier Quality, and Operations on issues, changes, complaints, and validations. The role covers complaint handling, investigations, CAPA, supplier quality, audits, and documentation reviews, with a lean team requiring both strategic and hands-on quality
We are currently recruiting a Quality Engineer, Med Tech | ISO 13485 & CAPA for our team in Eden Prairie, MN, United States.
Our organisation is growing, and we are hiring a Quality Engineer, Med Tech | ISO 13485 & CAPA in Eden Prairie, MN, United States.
This position is for the Quality Engineer, Med Tech | ISO 13485 & CAPA role at Nuwellis, Inc.
We are seeking a motivated Quality Engineer, Med Tech | ISO 13485 & CAPA to join Nuwellis, Inc. in Eden Prairie, MN, United States.
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