Quality Engineer II

Medtronic seeks a Quality Engineer II to support global service and repair operations in Minneapolis. The role involves ensuring compliance with quality system requirements, managing supplier quality, investigating quality issues, and driving continuous improvement across service center and field activities.

Responsibilities

• Partner cross-functionally to maintain quality system compliance and support operational objectives
• Develop and maintain quality standards, procedures, and controls for service and repair environment
• Investigate quality issues, assess risk, and lead corrective and preventive action implementation
• Manage supplier quality through audits, action requests, and performance monitoring
• Support validation activities, change control processes, and audit readiness across operations

Requirements

• Bachelor's degree in Engineering, Science, or technical field plus 2+ years quality or engineering experience
• Advanced degree in Engineering, Science, or technical field (0+ years experience acceptable)
• ISO 13485 Lead Auditor certification preferred
• Knowledge of ISO 14971 and medical device risk management principles
• Experience in regulated medical device industry and supplier quality processes
• Ability to investigate root causes and support CAPA and nonconformance management
• Proficiency with process validation, verification, and change control procedures