Senior Supplier Quality Engineer

iRhythm Technologies · Orange County, CA

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QualityFull-time$99k–$129kCompany career page

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Role summary

Senior Supplier Quality Engineer role ensuring global supply chain components meet technical specifications and quality standards at iRhythm Technologies. This position requires technical leadership in supplier auditing, defect reduction, and cross-functional collaboration within a fast-paced, high-volume medical device manufacturing environment.

What they're looking for

Bachelor's degree in Mechanical, Electrical, Industrial Engineering, or related technical field
Minimum 5 years quality/manufacturing engineering experience, or 3 years with master's degree
ISO 13485 Lead Auditor Certification
Direct medical device industry experience (ISO 13485, FDA, EUMDR compliance)
Expertise in process validation, capability studies, and statistical quality methods
ASQ CQE, CQA, or Six Sigma Green/Black Belt certification preferred
Experience with specialized manufacturing processes (PCBA, injection molding, machining, casting)

What you'll be doing

Conduct supplier audits and risk assessments to qualify suppliers against ISO standards
Lead Production Part Approval Process (PPAP) activities including validation and capability review
Manage Material Review Board process for non-conforming supplier materials and NCR disposition
Issue and drive Supplier Corrective Action Requests (SCARs) to resolution for high-risk failures
Develop supplier performance scorecards and conduct quarterly business reviews with critical vendors

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