New · posted Oct 15
iRhythm · Medical Devices
Senior Supplier Quality Engineer
- Orange County, CA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
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
- 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.
What you need
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 (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 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. 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.
What you'll do
- 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.
Pay
$99,000 – $129,000 a year
Employer providedEstimated Pay Range
$99,000.00 - $129,000.00
Where you'll work
Orange County, CAHybridOpen in Maps (opens in a new tab)
More jobs in Orange County, CAWorking conditions
Location
Orange County
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
From the posting
About iRhythm
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, iRhythm’s 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 @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com 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 [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
Equal opportunity, accessibility and legal noticesiRhythm's statements, word for word
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 [email protected]
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California84 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $99,000 | — | $129,000 |
| California (middle half) | $118,625 | $135,000 | $158,625 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: iRhythm's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not iRhythm's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk15
- Collaboration and leadership8
- GMP and compliance5
- Lab testing and methods3
- Investigations and CAPA3
- Validation and qualification3
- Documentation and SOPs2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
iRhythm on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 3
- Locations
By discipline
- Quality5 83%
- Regulatory1 17%
By level
- Manager2 33%
- Senior & Principal2 33%
- Director1 17%
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Senior Supplier Quality Engineer at iRhythm
Open until filled. $99K–$129K a year, employer provided.