Senior Supplier Quality Engineer

Career-defining. Life-changing.

At iRhythm youll 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 whats 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

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 suppliersincluding 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 methodologiesincluding 5-Whys Fishbone diagrams and Six Sigmato 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 bachelors degree in Mechanical Electrical Industrial Engineering or a related technical field.
• Minimum of 5 years of experience with a bachelors degree or 3 years with masters 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 (ISO13485 FDA EUMDR) required.
• Experience working with Contract Manufacturers/3rd Party Suppliers preferred.

Knowledge Skills and Abilities:

• 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.
• Experience managing specialized manufacturing processes like PCBA injection molding batteries CNC machining casting.

Work Environment / Other Requirements:

• Hybrid schedule with 23 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. Candidate must poses a passport.
• 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:

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

Estimated Pay Range

As a part of our core values we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds experiences skills and perspectives. iRhythm Technologies Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures including those who may have any difficulty using our online system. If you need such an accommodation you may contact us at

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect predict and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care iRhythms vision is to deliver better data better insights and better health for all.

Make iRhythm your path forward. Zio the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page and all communications regarding the application interview and hiring process will come from a @ email address. Please check any communications to be sure they come directly from @ email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate please contact Written offers of employment will be extended in a formal offer letter from an @ email address ONLY .

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