Onsite Senior Quality Engineer - Medical Devices

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

Job summary

iRhythm Technologies, Inc. in Cypress, CA is seeking a Sr. Quality Engineer to provide on-site quality support for high-volume manufacturing of regulated medical devices.

You will lead investigations, CAPAs, and data-driven improvements aligned with FDA 21 CFR 820, ISO 13485 and QMSR compliance. Your role requires a bachelor’s in engineering and at least 5 years in quality engineering within a regulated environment, with ERP/eQMS experience.

Qualifications

• Bachelor’s degree in engineering or related field.
• 5 years of quality engineering experience in a regulated industry.
• Experience in the medical device industry familiar with FDA requirements.
• Knowledge of 21 CFR 820, ISO 13485 and FDA QMSR.

Responsibilities

• Provide on-site quality engineering support for high-volume manufacturing.
• Lead investigations for nonconformances, deviations, and quality issues.
• Drive CAPA investigations, root cause analysis, and closures.
• Apply 5 Why, fishbone, and fault tree analysis for root-cause.
• Perform SPC and Cp/Cpk to monitor process capability.
• Collaborate cross-functionally to implement improvements.

Skills

CAPA

Nonconformance mgmt

Change control

Risk management ISO14971

Process validation IQ/OQ/PQ

SPC

Data-driven decisions

Cross-functional collab

Quality systems

FDA QMSR

Education

Bachelor’s degree in engineering

Tools

QAD

SAP

eQMS

Job description

iRhythm Technologies, Inc. in Cypress, CA is seeking a Sr. Quality Engineer to provide on-site quality support for high-volume manufacturing of regulated medical devices.

You will lead investigations, CAPAs, and data-driven improvements aligned with FDA 21 CFR 820, ISO 13485 and QMSR compliance. Your role requires a bachelor’s in engineering and at least 5 years in quality engineering within a regulated environment, with ERP/eQMS experience.