Senior Quality Engineer – Medical Devices, On-Site in OC

iRhythm Technologies, Inc.; California; Sur place; USD 99 000 - 129 000; Plein temps

Résumé du poste

iRhythm Technologies, a leader in digital healthcare, seeks a Sr. Quality Engineer to support high-volume manufacturing of regulated medical devices on-site in Cypress, CA.

You will partner with Engineering and Operations to ensure product quality, compliance, and continuous improvement. You will lead investigations, CAPA, risk management, and validation activities, leveraging SPC and Cp/Cpk analyses to drive data-based decisions and cross-functional collaboration.

Qualifications

• 5 years of Quality Engineering experience in a regulated industry.
• Experience in the medical device industry is required.
• Strong understanding of FDA-regulated manufacturing environments.
• Knowledge of CAPA, nonconformance, change control, risk management (ISO14971), and SPC.
• Experience with ERP systems and eQMS.

Responsabilités

• Provide on-site quality engineering support for high-volume manufacturing.
• Lead investigations for nonconformances, deviations, and quality issues.
• Support CAPA investigations and ensure corrective action effectiveness.
• Use SPC and Cp/Cpk to monitor process performance.
• Drive continuous improvement in manufacturing quality and operational excellence.
• Support validation activities (IQ/OQ/PQ) for equipment and processes.

Connaissances

Analytical thinking

Problem-solving

Data-driven decisions

Cross-functional collab

Root-cause investigations

Regulatory compliance

Quality systems

Formation

Bachelor’s degree in engineering

Outils

QAD

SAP

eQMS

Description du poste

iRhythm Technologies, a leader in digital healthcare, seeks a Sr. Quality Engineer to support high-volume manufacturing of regulated medical devices on-site in Cypress, CA.

You will partner with Engineering and Operations to ensure product quality, compliance, and continuous improvement. You will lead investigations, CAPA, risk management, and validation activities, leveraging SPC and Cp/Cpk analyses to drive data-based decisions and cross-functional collaboration.