Quality Control Manager

Full-time

iRhythm Technologies

iRhythm Technologies seeks a Quality Control Manager to lead inspection and material control operations across manufacturing and receiving in Orange County. The role involves directing quality inspectors, ensuring regulatory compliance, managing nonconformances, and driving continuous improvement on the production floor.

Responsibilities

Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel
Develop and implement inspection plans, sampling strategies, and control plans with cross-functional partners
Oversee identification, documentation, and containment of nonconforming material and support MRB activities
Review and verify manufacturing batch records and travelers for completeness and regulatory compliance prior to lot release
Monitor quality metrics, conduct Gemba walks, and drive continuous improvement initiatives

Requirements

Leadership experience managing quality inspection or manufacturing teams
Knowledge of FDA 21 CFR 820 and ISO 13485 requirements
Experience with batch record review and documentation control
Proficiency in nonconformance management and material review boards
Receiving inspection and first-article inspection (FAI) experience
Understanding of inspection plans, sampling strategies, and control plans

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Vacancy posted 1 day ago

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