Senior Quality Engineer – Medical Devices, Onsite

iRhythm Technologies, Inc.; California; On-site; USD 99,000 - 129,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Sr. Quality Engineer on site in Cypress, CA to support manufacturing quality and regulatory compliance.

You will lead nonconformance investigations, CAPA programs, and data-driven quality improvements across production teams. The role requires a BA in engineering and 5 years of quality engineering experience in a regulated medical device environment, with expertise in CAPA, SPC, IQ/OQ/PQ, and risk management.

Qualifications

• Bachelor's degree in engineering (Mechanical, Biomedical, Electrical, Industrial)
• 5 years of Quality Engineering experience in a regulated industry
• Experience in FDA-regulated manufacturing environments
• Experience with CAPA, Nonconformance, Change control, ISO14971, IQ/OQ/PQ, SPC, and process validation
• Experience with ERP systems (QAD, SAP) and eQMS

Responsibilities

• Provide daily on-site quality engineering support to manufacturing operations.
• Partner with production teams to ensure product quality, compliance, and timely resolution of quality issues.
• Lead investigations for nonconformances and deviations using root cause analysis.
• Lead or support CAPA investigations and ensure effectiveness and closure.
• Analyze manufacturing data using SPC and Cp/Cpk to identify trends and improve processes.
• Drive continuous improvement to enhance yield, process stability, and product quality.
• Support IQ/OQ/PQ validation activities and review validation docs.
• Review ECOs for quality/regulatory impact and support risk management.

Skills

CAPA

Nonconformance

Change Control

Risk Management

IQ/OQ/PQ

SPC

DOE

Minitab

Education

Bachelor’s degree in engineering

Tools

QAD

SAP

eQMS

Job description

iRhythm Technologies, Inc. is seeking a Sr. Quality Engineer on site in Cypress, CA to support manufacturing quality and regulatory compliance.

You will lead nonconformance investigations, CAPA programs, and data-driven quality improvements across production teams. The role requires a BA in engineering and 5 years of quality engineering experience in a regulated medical device environment, with expertise in CAPA, SPC, IQ/OQ/PQ, and risk management.