Senior Supplier Quality Engineer - Medical Devices (Hybrid)

El Camino Health; California; Hybrid; USD 99,000 - 129,000; Full time

Benefits offered by this job

Hybrid work schedule

Travel up to 25%

Competitive compensation

Job summary

iRhythm Technologies, Inc. in Orange County, CA is hiring a Senior Supplier Quality Engineer to drive supplier quality across high‑volume medical device production.

You will lead audits, PPAP, MRB, and SCAR activities, partnering with Engineering, Sourcing, and Manufacturing to ensure CTQs and process capabilities before release. The role requires ISO13485, FDA/EUMDR familiarity, and hands‑on Six Sigma/Lean problem solving in a fast‑paced environment; travel up to 25% domestically and

Qualifications

• Minimum bachelor’s degree in Mechanical, Electrical, Industrial Engineering, or a related technical field.
• Minimum of 5 years with a bachelor’s degree, or 3 years with a master’s, in Quality or Manufacturing Engineering.
• Lead Auditor ISO 13485 OR ASQ CQE OR CQA OR Six Sigma Green/Black Belt preferred.
• Direct experience in the Medical Device industry (ISO13485, FDA, EUMDR) required.
• Experience with Contract Manufacturers/3rd Party Suppliers preferred.

Responsibilities

• Supplier audits & qualification to ISO 9001 / ISO 13485.
• Lead PPAP activities with suppliers to establish process capability.
• Own MRB process; contain and disposition NCRs.
• Issue and manage Supplier Corrective Action Requests (SCARs).
• Root cause analysis using 5-Whys, Fishbone, Six Sigma.
• Collaborate with Engineering during NPI; align CTQ characteristics.
• Analyze quality metrics; generate supplier scorecards & QBRs.
• Drive cost-reduction and yield-improvement with Six Sigma/Lean.

Skills

Quality engineering

Supplier management

Root cause analysis

Process validation

DOE/IQ/OQ/PQ

Gage R&R

Cross-functional collaboration

Six Sigma

Project management

CPK / Quality metrics

Education

Bachelor's in Mechanical/ Electrical/ Industrial Engineering

Job description

iRhythm Technologies, Inc. in Orange County, CA is hiring a Senior Supplier Quality Engineer to drive supplier quality across high‑volume medical device production.

You will lead audits, PPAP, MRB, and SCAR activities, partnering with Engineering, Sourcing, and Manufacturing to ensure CTQs and process capabilities before release. The role requires ISO13485, FDA/EUMDR familiarity, and hands‑on Six Sigma/Lean problem solving in a fast‑paced environment; travel up to 25% domestically and