Senior Quality Engineer (Onsite) – Medical Devices

Regulatory Jobs; Cypress (CA); On-site; USD 99,000 - 129,000; Full time

Job summary

iRhythm Technologies in Cypress, CA seeks a Sr. Quality Engineer to provide on-site quality engineering support for high-volume regulated medical device manufacturing.

You will collaborate with Engineering and Operations to ensure quality and regulatory compliance while driving continuous process improvement. The role leads investigations, CAPA, change control, and data analysis using SPC/Cp/Cpk, IQ/OQ/PQ, and ISO 13485/QMSR, requiring strong cross-functional collaboration and problem-solving

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
• ERP systems experience (QAD, SAP)
• Experience with electronic Quality Management Systems (eQMS)

Responsibilities

• Provide on-site quality engineering support to manufacturing operations
• Partner with production to ensure product quality and compliance
• Lead nonconformance investigations and CAPA activities
• Support validation activities (IQ/OQ/PQ) for equipment/processes
• Drive continuous improvement and data-driven decision making
• Review ECOs for quality/regulatory impact
• Support quality systems compliance and audits

Skills

Analytical thinking

Problem solving

Cross-functional collaboration

Data-driven decision making

Regulatory knowledge

Education

Bachelor’s degree in engineering

ASQ Certified Quality Engineer (CQE)

ISO 13485 Lead Auditor certification

Six Sigma Green Belt/Black Belt

Tools

QAD

SAP

eQMS

Minitab

Job description

iRhythm Technologies in Cypress, CA seeks a Sr. Quality Engineer to provide on-site quality engineering support for high-volume regulated medical device manufacturing.

You will collaborate with Engineering and Operations to ensure quality and regulatory compliance while driving continuous process improvement. The role leads investigations, CAPA, change control, and data analysis using SPC/Cp/Cpk, IQ/OQ/PQ, and ISO 13485/QMSR, requiring strong cross-functional collaboration and problem-solving