Quality Engineer

Confidential

📍 Anoka, Minnesota, United States

Full-time Engineers

Job Description

Quality Engineer – New Product Development & Manufacturing Transfer

Join a fast-paced medical device manufacturing environment where quality drives innovation. As a Quality Engineer, you will play a key role in bringing new products from concept to commercial production, ensuring compliance, reliability, and manufacturing excellence every step of the way.

What You'll Do

  • Lead quality activities for new product development (NPD), design transfer, and manufacturing transfer projects.
  • Partner with Engineering, Operations, Supply Chain, and customers to ensure products meet regulatory and quality requirements.
  • Drive process qualification and validation activities (IQ/OQ/PQ) to support successful product launches.
  • Conduct risk assessments using dFMEA, pFMEA, control plans, and other quality tools to identify and mitigate potential issues.
  • Support supplier qualification, process capability studies, and ma...
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