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JCW Group

Quality Engineer - Design Assurance

JCW Group, Minneapolis, Minnesota, United States, 55400

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Were seeking a

Design Assurance Engineer

to join an innovative medical device team. In this role, youll 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.