New · posted Oct 23
iRhythm · Medical Devices
Sr. Quality Engineer
- Cypress, CA
- On-site
- 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
Position: Sr. Quality Engineer
Reports to: Manager, Manufacturing Quality Engineering
Location: On site Cypress, CA
The Senior Quality Engineer provides on-site quality engineering support for high-volume manufacturing operations of regulated medical devices. This role partners closely with Engineering and Operations to ensure product quality, regulatory compliance, and continuous improvement of manufacturing processes.
The Sr. Quality Engineer leads manufacturing quality investigations, supports manufacturing quality systems, and drives corrective and preventive actions (CAPA) in compliance with FDA Quality System Regulation (21 CFR 820), the FDA Quality Management System Regulation (QMSR), ISO 13485, and internal quality standards. This position plays a key role in ensuring that manufacturing processes operate with the highest standards of quality, compliance, and operational excellence.
What you need
Education
Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial)
Experience
5 years of Quality Engineering experience in a regulated industry
Experience in the medical device industry required
Strong understanding of FDA-regulated manufacturing environments
Quality System Expertise: Demonstrated experience with: CAPA, Nonconformance management, Change control processes, Risk management (ISO14971), Process validation (IQ/OQ/PQ), Statistical Process Control (SPC) and process capability analysis
Regulatory Knowledge: Working knowledge of 21 CFR 820, ISO 13485, and FDA QMSR (Quality Management System Regulation)
Systems Experience: Experience with Enterprise Resource Planning (ERP) systems (i.e. QAD, SAP)
Experience using electronic Quality Management Systems (eQMS)
Preferred Skillsnice to have
Master’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial, or related field)
ASQ Certified Quality Engineer (CQE)
Six Sigma Green Belt or Black Belt
ISO 13485 Lead Auditor certification
Experience in high-volume manufacturing environments
Experience supporting electromechanical or wearable medical devices
Familiarity with Design of Experiments (DOE) and statistical software such as Minitab
Key Competencies
Strong analytical and problem-solving skills
Ability to lead complex root cause investigations
Data-driven decision making
Cross-functional collaboration with operations and engineering teams
Strong understanding of manufacturing quality systems
Ability to balance operational urgency with regulatory compliance
What you'll do
Manufacturing Quality Support
· Provide daily on-site quality engineering support to manufacturing operations.
· Partner with production teams to ensure product quality, compliance, and efficient resolution of quality issues.
· Participate in Material Review Board (MRB) activities and approve nonconforming product dispositions
· Represent Quality in production escalation and operational review meetings.
Nonconformance & Investigation Leadership
· Lead investigations for nonconformances, deviations, and manufacturing quality issues.
· Apply structured root cause analysis methodologies including: 5 Why, Fishbone, Fault Tree Analysis
· Ensure investigations are data-driven, thorough, and compliant with regulatory expectations.
CAPA Ownership
· Lead or support Corrective and Preventive Action (CAPA) investigations and implementation.
· Ensure robust root cause identification, corrective action effectiveness, and timely closure.
· Collaborate cross-functionally to implement systemic improvements.
Statistical Quality & Data Analysis
· Analyze manufacturing data to identify trends, risks, and opportunities for improvement.
· Utilize Statistical Process Control (SPC) and process capability analysis (Cp/Cpk) to evaluate process performance.
· Support implementation of statistical methods to improve manufacturing robustness.
· Identify opportunities for process capability improvement and defect reduction using statistical methods and structured problem-solving techniques.
Continuous Improvement & Operational Excellence
· Drive continuous improvement initiatives to enhance manufacturing process capability, product quality, and operational efficiency
· Analyze production and quality data to identify systemic issues, trends, and improvement opportunities
· Lead cross-functional problem-solving activities to reduce defects, scrap, rework, and recurring nonconformances
· Partner with Operations and Engineering teams to implement process improvements and mistake-proofing (poka-yoke) solutions.
· Support initiatives to improve manufacturing yield, process stability, and overall product quality performance.
· Monitor and report quality metrics and process performance indicators to drive data-informed decision making.
Process Validation Support
· Support process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes.
· Review and approve validation protocols and reports.
· Ensure validation documentation meets regulatory and internal quality requirements.
Change Control & Risk Management
· Review and support Engineering Change Orders (ECO) to ensure appropriate quality and regulatory impact assessment
· Ensure risk management activities align with ISO 14971 requirements.
· Provide quality input during manufacturing and process changes
Quality Systems Compliance
· Ensure manufacturing quality processes align with 21 CFR 820, FDA QMSR, ISO 13485
· Support internal audits, regulatory inspections, and compliance initiatives as needed.
Pay
$99,000 – $129,000 a year
Employer providedEstimated Pay Range
$99,000.00 - $129,000.00
Where you'll work
Cypress, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cypress, 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 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California91 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $99,000 | — | $129,000 |
| California (middle half) | $115,750 | $135,500 | $157,250 |
| All US (middle half) | $102,500 | $119,000 | $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 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 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 63 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk15
- Collaboration and leadership13
- Investigations and CAPA12
- GMP and compliance9
- Lab testing and methods5
- Validation and qualification5
- Documentation and SOPs4
- Data and digital systems2
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.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
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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Sr. Quality Engineer at iRhythm
Open until filled. $99K–$129K a year, employer provided.