Senior Supplier Quality Engineer - Hybrid, Global Impact

Regulatory Jobs; California; Hybrid; USD 99,000 - 129,000; Full time

Benefits offered by this job

Hybrid schedule

Travel opportunities

Job summary

iRhythm Technologies in Orange County is seeking a Senior Supplier Quality Engineer to lead quality across global supplier networks, ensuring parts meet ISO9001/13485 standards and feed production lines with reliable components. You will audit suppliers, drive PPAP, lead MRB, and collaborate with Engineering, Sourcing, and Production to reduce defects.

Hybrid schedule, travel up to 25%, and a focus on Six Sigma and continuous improvement.

Qualifications

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

Responsibilities

• Perform supplier audits and qualification to qualify suppliers.
• Lead PPAP activities and process validation.
• Own MRB process to manage non-conforming parts.
• Issue supplier corrective actions (SCARs) and drive permanent resolution.
• Conduct root cause analysis using 5-Whys, Fishbone, and Six Sigma.
• Support NPI with CTQ characteristics and inspection alignment.
• Monitor quality metrics and prepare supplier scorecards and QBRs.
• Lead continuous improvement projects with Six Sigma and Lean.

Skills

Quality Engineering

Auditing

PPAP

Root Cause Analysis

Six Sigma

Gage R&R

Supplier management

Cross-functional collaboration

Education

Bachelor's degree in Mechanical, Electrical, or Industrial Engineering

Lead Auditor Certified ISO 13485 / CQE / CQA or Six Sigma

Tools

Job description

iRhythm Technologies in Orange County is seeking a Senior Supplier Quality Engineer to lead quality across global supplier networks, ensuring parts meet ISO9001/13485 standards and feed production lines with reliable components. You will audit suppliers, drive PPAP, lead MRB, and collaborate with Engineering, Sourcing, and Production to reduce defects.

Hybrid schedule, travel up to 25%, and a focus on Six Sigma and continuous improvement.