Quality Engineer: Regulatory Compliance & CI

Job description

Delcath Systems, Inc. is seeking a Quality Engineer to help establish and maintain the Quality System, ensuring compliance with FDA, ISO regulations, and Medical Device Directives.

You will support GMP compliance alongside the QA Manager and participate in design and risk management activities. The role emphasizes quality system development, design verification/validation, supplier quality, and internal audits, with a focus on cross-functional collaboration and process improvement.

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Who can apply

Review the original listing for work authorization, qualifications and employer requirements.