Senior Quality Engineer, Medical Devices & CAPA Leader

IRhythm Technologies Inc.; Santa Ana (CA); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

iRhythm on-site in Cypress, CA seeks a Sr. Quality Engineer to support high-volume medical device manufacturing and drive quality and regulatory compliance.

You will lead CAPAs, investigations, MRB activities, and apply SPC and CpK analyses to improve yield and robustness, partnering with Engineering and Operations.

This role emphasizes process validation support, change control, risk management, and adherence to FDA 21 CFR 820, ISO 13485, and internal standards.

Formación

• Bachelor's degree in engineering or related field.
• Minimum 5 years of quality engineering in regulated industry.
• Experience in the medical device manufacturing and FDA environments.
• Strong CAPA, nonconformance, and change control knowledge.

Responsabilidades

• Provide on-site quality engineering support for high-volume manufacturing.
• Lead investigations of nonconformances and deviations.
• Own CAPA investigations and ensure timely closures.
• Analyze manufacturing data using SPC and Cp/Cpk.
• Drive continuous improvement to reduce defects and waste.
• Support IQ/OQ/PQ validation activities.
• Review ECOs for quality/regulatory impact.
• Ensure compliance with 21 CFR 820, QMSR, and ISO 13485.

Conocimientos

Quality engineering

CAPA

Data analysis

Root cause analysis

SPC

Process improvement

Educación

Bachelor's degree in engineering

Herramientas

MRB

SPC software

IQ/OQ/PQ validation

ISO 13485 familiarity

Descripción del empleo

iRhythm on-site in Cypress, CA seeks a Sr. Quality Engineer to support high-volume medical device manufacturing and drive quality and regulatory compliance.

You will lead CAPAs, investigations, MRB activities, and apply SPC and CpK analyses to improve yield and robustness, partnering with Engineering and Operations.

This role emphasizes process validation support, change control, risk management, and adherence to FDA 21 CFR 820, ISO 13485, and internal standards.