Quality Assurance Engineer
4 weeks ago
ICU Medical is seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our medical devices and processes.
Key Responsibilities
• Support initiatives for continuous quality improvements
• Work under the guidance of the Quality leadership to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance needs
• Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
• Provide quality technical expertise for a manufacturing production line
• Create and edit documents to support Quality
• Participate in vendor assessment and review of materials/machine technical information
Requirements
• Bachelor's degree from an accredited college or university in Engineering
• 0-2 years' experience in the Medical Device or Engineering Industry
• Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
• Technical writing competency
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