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Quality Engineer - Design Assurance

Quality Engineer - Design Assurance

JCW GroupMinneapolis, MN, United States
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We’re seeking a Design Assurance Engineer to join an innovative medical device team. In this role, you’ll lead design assurance activities, support new product development, and ensure compliance with regulatory standards.

Key Responsibilities :

  • Lead design assurance activities, including verification, validation, and risk management.
  • Collaborate with cross-functional teams to implement best practices in design controls.
  • Prepare and review technical documentation to support regulatory compliance.

Qualifications :

  • 5+ years of experience in design assurance within the medical device industry.
  • Strong knowledge of FDA, ISO, and IEC regulations and standards.
  • Excellent problem-solving, analytical, and communication skills.
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    Quality Assurance Engineer • Minneapolis, MN, United States