Senior Supplier Quality Engineer

## Senior Supplier Quality Engineer Apply:
Hybrid:
Orange County, CA:
Full time:
Posted 2 Days Ago:
JR1752
** Career-defining. Life-changing.
** At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives.

We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
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* About This Role:

***
* About This Role:

*** The Senior Supplier Quality Engineer (Sr. SQE) ensures that the global supply chain delivers components, assemblies, and materials that meet all technical specifications and quality standards. This role thrives in a fast-paced, high-growth environment characterized by high-volume production schedules and rapid product development cycles. You will serve as the primary quality interface between our suppliers and manufacturing partners. This role requires technical leadership, data-driven defect reduction, and extensive collaboration with Engineering, Sourcing, and Production teams to mitigate risk before parts hit the manufacturing floor.
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* Essential Duties and Responsibilities:

*** Supplier Audits &

Qualification:

Conduct rigorous risk assessments and quality system audits (e.g., ISO 9001, ISO 13485) at supplier facilities to qualify suppliers.
* Conducting Component

Qualification:

Lead, review, and approve the end-to-end Production Part Approval Process (PPAP). Actively participate in conducting PPAP activities with suppliers—including Process Validation, Test Method validation, reviewing Process Flow Diagrams, Process FMEAs (PFMEA), Control Plans, to validate process capability before production release.
* Non-Conformance Control:
Own the Material Review Board (MRB) process for supplier materials. Rapidly isolate, contain, and disposition non-conforming parts (NCRs) to minimize production downtime and protect assembly line velocity.
* Agile SCAR Ownership:
Issue and manage formal Supplier Corrective Action Requests (SCARs) for high-risk failures. Drive suppliers to permanent resolution.
* Root Cause Analysis:
Champion data-driven problem-solving methodologies—including 5-Whys, Fishbone diagrams, and Six Sigma—to quickly diagnose and solve complex technical defects under high-pressure conditions.
* New Product Introduction (NPI):
Partner with Engineering during design phases to evaluate supplier capability, establish critical-to-quality (CTQ) characteristics, and establish inspection alignments between internal and vendor sites.
* Performance Monitoring:
Analyze quality metrics (DPPM, SCAR response time, yield rates) to generate monthly supplier scorecards and run quarterly business reviews (QBRs) for critical vendors.
* Continuous Improvement:
Initiate cost-reduction, yield-improvement, and process-capability (Cpk) projects alongside suppliers using Six Sigma and Lean methodologies.
** Experience and

Minimum Qualifications:

*** Minimum bachelor’s degree in Mechanical, Electrical, Industrial Engineering, or a related technical field.
* Minimum of 5 years of experience with a bachelor’s degree, or 3 years with master’s degree, in Quality Engineering, or Manufacturing Engineering with hands-on experience.
* Lead Auditor Certified (ISO 13485) OR ASQ Certified Quality Engineer (CQE) OR Certified Quality Auditor (CQA) OR a Six Sigma Green/Black Belt certification preferred.
* Direct experience in the Medical Device industry (ISO
13485, FDA, EUMDR) required.
*…