Senior Supplier Quality Engineer – MedDevice (Hybrid)

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

Job summary

iRhythm Technologies is seeking a Senior Supplier Quality Engineer to ensure the global supply chain delivers components that meet quality standards and regulatory requirements. You will serve as the primary quality interface between suppliers and manufacturing partners, leading audits, PPAP activities, MRB, SCARs, and root-cause investigations in a fast-paced, high-growth environment.

Based in Orange County with a hybrid schedule, you will collaborate with Engineering, Sourcing, and Production

Qualifications

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

Responsibilities

• Audit suppliers and qualification activities (ISO 9001, ISO 13485).
• Lead PPAP activities including Process Validation, Test Method validation, PFMEA, Control Plans.
• Own MRB process for supplier materials and disposition NCRs.
• Issue and manage SCARs for high-risk failures and drive permanent resolution.
• Lead root-cause analyses using 5-Whys, Fishbone, Six Sigma.
• Collaborate on New Product Introduction to establish CTQ and inspection alignments.
• Monitor quality metrics and generate supplier scorecards; lead QBRs.
• Drive continuous improvement projects with Six Sigma/Lean.

Skills

Quality leadership

Root cause analysis

Cross-functional collaboration

Supplier negotiations

Process improvement

PCBA, injection molding, batteries, CN

Education

Bachelors in Mechanical Engineering

Bachelors in Electrical Engineering

Bachelors in Industrial Engineering

Tools

PPAP

Gage R&R

Six Sigma

Job description

iRhythm Technologies is seeking a Senior Supplier Quality Engineer to ensure the global supply chain delivers components that meet quality standards and regulatory requirements. You will serve as the primary quality interface between suppliers and manufacturing partners, leading audits, PPAP activities, MRB, SCARs, and root-cause investigations in a fast-paced, high-growth environment.

Based in Orange County with a hybrid schedule, you will collaborate with Engineering, Sourcing, and Production