Quality Control Manager

IRhythm Technologies Inc.; Aliso Viejo (CA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

iRhythm Technologies seeks a Quality Control Manager to lead inspection and material control across manufacturing and receiving in Orange County. You will direct quality inspectors, develop plans, and ensure regulatory compliance before lot release.

Responsibilities include mentoring teams, reviewing batch records, monitoring quality metrics, and driving continuous improvement on the production floor. The role requires FDA 21 CFR 820 and ISO 13485 knowledge, plus MRB and FAI experience.

Formación

• Experience leading quality inspection or manufacturing teams.
• Knowledge of FDA 21 CFR 820 and ISO 13485 requirements.
• Experience with batch record review and documentation control.

Responsabilidades

• 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.

Conocimientos

Leadership

Regulatory knowledge

Batch records review

Nonconformance management

MRB

Receiving inspection

FAI

Inspection plans

Sampling strategies

Control plans

Descripción del empleo

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