Senior Quality Engineer - Medical Devices, CAPA & CI

IRhythm Technologies Inc.; California; On-site; USD 110,000 - 150,000; Full time

Job summary

iRhythm Technologies Inc. in Cypress, CA, is hiring a Sr. Quality Engineer to provide on-site quality engineering support for high-volume medical device manufacturing, ensuring product quality and regulatory compliance.

You will lead investigations for nonconformances, CAPA actions, change control, MRB activities, and data-driven quality improvements using SPC, Cp/Cpk, and risk management in a fast-paced environment.

Experience in FDA-regulated settings and ISO 13485 is required.

Qualifications

• Bachelor’s degree in engineering
• 5 years of Quality Engineering experience in a regulated industry
• Experience in the medical device industry
• Strong understanding of FDA-regulated manufacturing environments
• Quality System Expertise: CAPA, Nonconformance management, Change control processes, Risk management

Responsibilities

• Provide daily on-site quality engineering support to manufacturing operations.
• Partner with production teams to ensure product quality, compliance, and efficient resolution of quality issues.
• Lead investigations for nonconformances, deviations, and manufacturing quality issues.
• Apply structured root cause analysis methodologies including: 5 Why, Fishbone, Fault Tree Analysis
• Lead or support CAPA investigations and implementation.
• Analyze manufacturing data to identify trends, risks, and opportunities for improvement.
• Drive continuous improvement initiatives to enhance manufacturing process capability, product quality, and operational efficiency
• Support process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes
• Review and support Engineering Change Orders (ECO) for quality impact assessment
• Ensure manufacturing quality processes align with 21 CFR 820, FDA QMSR, ISO 13485

Skills

CAPA

Nonconformance management

Change control

Risk management

FDA 21 CFR 820

ISO 13485

Statistical analysis

Process validation

Education

Bachelor’s degree in engineering

Job description

iRhythm Technologies Inc. in Cypress, CA, is hiring a Sr. Quality Engineer to provide on-site quality engineering support for high-volume medical device manufacturing, ensuring product quality and regulatory compliance.

You will lead investigations for nonconformances, CAPA actions, change control, MRB activities, and data-driven quality improvements using SPC, Cp/Cpk, and risk management in a fast-paced environment.

Experience in FDA-regulated settings and ISO 13485 is required.