Senior Quality Engineer - Medical Devices (Onsite CA)

iRhythm Technologies, Inc.; Anaheim (CA); On-site; USD 99,000 - 129,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Sr. Quality Engineer for on-site support in Cypress, CA. You will lead quality investigations, CAPA activities, and data-driven improvements across high-volume manufacturing of regulated medical devices.

The role requires 5 years of quality engineering in regulated environments, familiarity with FDA/QMSR standards, and ERP/eQMS experience to enhance product quality and compliance.

Qualifications

• Bachelor's degree in engineering (Mechanical, Biomedical, Electrical, Industrial).
• 5 years of Quality Engineering experience in a regulated industry.
• Experience in the medical device industry required.
• Strong understanding of FDA-regulated manufacturing environments.
• Quality System Expertise: CAPA, Nonconformance, Change control, Risk management (ISO14971), IQ/OQ/PQ, SPC and CP/CPk.
• Regulatory Knowledge: 21 CFR 820, ISO 13485, FDA QMSR.

Responsibilities

• Manufacturing Quality Support: on-site quality engineering for manufacturing operations.
• Nonconformance & Investigation Leadership: lead investigations and ensure data-driven findings.
• CAPA Ownership: investigate and implement corrective and preventive actions.
• Statistical Quality & Data Analysis: analyze data using SPC and Cp/Cpk.
• Continuous Improvement: drive process improvements and defect reduction.
• Process Validation Support: assist IQ/OQ/PQ for equipment and processes.
• Change Control & Risk Management: review ECOs and ensure ISO14971 alignment.
• Quality Systems Compliance: ensure compliance with 21 CFR 820, QMSR, ISO 13485.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in engineering

Tools

QAD

SAP

eQMS

Job description

iRhythm Technologies, Inc. is seeking a Sr. Quality Engineer for on-site support in Cypress, CA. You will lead quality investigations, CAPA activities, and data-driven improvements across high-volume manufacturing of regulated medical devices.

The role requires 5 years of quality engineering in regulated environments, familiarity with FDA/QMSR standards, and ERP/eQMS experience to enhance product quality and compliance.