Senior Supplier Quality Engineer – Medical Devices

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

Job summary

iRhythm Technologies, Inc. seeks a Senior Supplier Quality Engineer (Sr. SQE) to lead supplier quality across the global supply chain. The role interfaces with Engineering, Sourcing, and Production to mitigate risk before parts hit the line and ensures compliance with ISO 13485/FDA standards.

Responsibilities include supplier audits, PPAP activities, MRB ownership, SCAR management, and data-driven root-cause analysis. Hybrid schedule in Orange County, with up to 25% travel.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Industrial Engineering or related field.
• Minimum 5 years in Quality/Manufacturing Engineering; 3 years with master's degree.
• Lead Auditor Certified (ISO 13485) preferred; required certification is a plus.

Responsibilities

• Conduct supplier audits and qualification activities (ISO 9001/13485).
• Lead PPAP activities with suppliers; validate process capability before production release.
• Own MRB process for supplier materials and disposition non-conforming parts.

Skills

Quality engineering

Auditing

Root cause analysis

Six Sigma

Cross-functional collaboration

PPAP

DOE

Gage R&R

Process capability

Regulatory compliance

Education

Bachelor's degree in Mechanical/Electrical/Industrial Engineering

Tools

PPAP

DOE

Gage R&R

QC tools

Job description

iRhythm Technologies, Inc. seeks a Senior Supplier Quality Engineer (Sr. SQE) to lead supplier quality across the global supply chain. The role interfaces with Engineering, Sourcing, and Production to mitigate risk before parts hit the line and ensures compliance with ISO 13485/FDA standards.

Responsibilities include supplier audits, PPAP activities, MRB ownership, SCAR management, and data-driven root-cause analysis. Hybrid schedule in Orange County, with up to 25% travel.