iRhythm Technologies, Inc.

Senior Supplier Quality Engineer

iRhythm Technologies, Inc. • $99K — $129K *
Orange, CA 92867In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Mechanical, Electrical, Industrial Engineering, or related field.
  • 5+ years of Quality Engineering or Manufacturing Engineering experience (3+ years with a master's degree).
  • Lead Auditor Certified (ISO 13485).
  • Direct experience in the Medical Device industry (ISO 13485, FDA, EUMDR).
  • Strong expertise in executing validations and process control strategies.

Responsibilities

  • Conduct risk assessments and quality system audits at supplier facilities.
  • Lead and approve the Production Part Approval Process (PPAP).
  • Manage the Material Review Board (MRB) process for supplier materials.
  • Issue and manage Supplier Corrective Action Requests (SCARs) for high-risk failures.
  • Champion data-driven problem-solving methodologies for defect analysis.
  • Partner with Engineering on supplier capability evaluations during new product introductions.
  • Analyze quality metrics and generate supplier scorecards.

Benefits

  • Hybrid work schedule with 2-3 days in-office.
  • Up to 25% travel for supplier audits and problem-solving.
  • Opportunities for continuous learning and professional development.
Full Job Description
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.
  • 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:
  • Education: Minimum bachelor's degree in Mechanical, Electrical, Industrial Engineering, or a related technical field.
  • Experience: 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.
  • Certification: Lead Auditor Certified (ISO 13485)


Knowledge, Skills and Abilities:
  • Direct experience in the Medical Device industry (ISO13485, FDA, EUMDR)
  • Strong technical expertise executing, validations, including process capability studies (DOE, IQ, OQ, PQ), Gage R&R studies, and process control strategies.
  • Proven track record of operating successfully in a fast-paced environment with minimal supervision and high ambiguity.
  • Proven track record of independently leading formal root-cause analysis investigations and deploying sustainable corrective actions.
  • Exceptional cross-functional collaboration with negotiation skills, with the ability to confidently influence external supplier leadership and internal executives under high-pressure situations.
  • Lead Auditor Certified, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or a Six Sigma Green/Black Belt certification.
  • Experience managing specialized manufacturing processes like PCBA, injection molding, batteries, CNC machining, casting.


Work Environment / Other Requirements:
  • Hybrid schedule with 2-3 days per week in the office, based on business needs and team requirements.
  • Travel up to 25% domestically and internationally to visit supplier sites for audits and critical problem-solving sessions.
  • Physical Requirements: Ability to remain in a stationary position for extended periods, operate a computer and standard office equipment, communicate effectively in meetings and supplier interactions, and occasionally stand, walk, or move within manufacturing and supplier environments during audits or inspections.
  • Mental Demands: Ability to analyze complex technical and quality data, make sound risk-based decisions under time-sensitive conditions, manage multiple priorities, maintain attention to detail, and communicate clearly with cross-functional teams, suppliers, and leadership in high-pressure situations.
    #LI-Hybrid
    #LI-LM1


Location:
Orange County

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range
$99,000.00 - $129,000.00

About iRhythm Technologies, Inc.

iRhythm Technologies is a medical device company that develops and commercializes solutions for cardiac arrhythmia detection. The company's flagship product is the Zio XT, a wearable patch that continuously monitors a patient's heart rhythm for up to 14 days. The Zio XT is designed to improve the detection and diagnosis of cardiac arrhythmias, which can be difficult to diagnose due to their intermittent nature. iRhythm Technologies was founded in 2006 and is headquartered in Redwood City, California. The company went public in 2016 and is traded on the NASDAQ stock exchange under the ticker symbol IRTC.
Learn more about iRhythm Technologies, Inc.
Size
1,700 employees
Market Cap
$2.7 billion
Industry
Healthcare
Net Income
-$43.8 million
Founded
2006
5 Year Trend
+38.2%
Revenue
$265.1 million
NASDAQ
IRTC
* Ladders Estimates

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