Full-Time
Quality Control Manager
Updated on 8/1/2026
iRhythm Technologies
1,001-5,000 employees
Wearable cardiac monitoring with data analysis
Compensation Overview
$112k - $145k/yr
Orange County, CA, USA
In Person
 QA & Testing (1) |
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- A bachelor's degree in Life Sciences, Engineering, or a related technical discipline is required.
- A minimum of 8 years of progressive experience in a medical device manufacturing environment is required, with responsibility for quality control, inspection, or manufacturing quality operations.
- Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 is required, with working familiarity with EU MDD and EU MDR requirements.
- Demonstrated ability to identify, investigate, and resolve complex quality and manufacturing issues, including nonconformances, Material Review Board activities, deviations, and corrective actions.
- Proven experience collaborating with Manufacturing, Quality Engineering, Supplier Quality, Engineering, Operations, and Facilities/Maintenance teams.
- High attention to detail, with a strong focus on timeliness, data accuracy, and Good Documentation Practices compliance.
- Strong verbal and written communication skills, with the ability to communicate expectations, risks, and decisions at all organizational levels.
- Working knowledge of statistical and quality tools, including trend analysis, process capability using Cp/Cpk and Pp/Ppk, Gage R&R, and defect trend analysis.
- Working knowledge of medical device risk management, including process failure mode and effects analyses and alignment with ISO 14971 principles.
- Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
- Ensure inspectors are trained and qualified to perform inspections and documentation according to approved procedures.
- Establish expectations and accountability for inspection accuracy, documentation integrity, and timely escalation of quality issues.
- Support the development, implementation, and continuous improvement of inspection plans, sampling strategies, and control plans with Quality Engineering, Supplier Quality, and Manufacturing Engineering.
- Ensure effective in-process, final, and receiving inspections are executed according to approved inspection plans and work instructions.
- Drive improvements to inspection efficiency, first-pass yield, and defect containment across manufacturing operations.
- Ensure timely identification, documentation, and containment of nonconforming material in manufacturing and receiving.
- Support and participate in Material Review Board activities, ensuring accurate disposition execution and documentation.
- Support planned deviations while ensuring risk assessments, approvals, and documentation are completed according to the Quality Management System.
- Ensure dispositions, deviations, and containment actions are accurately reflected in work orders, travelers, and batch records.
- Ensure proper material identification, segregation, labeling, and traceability from receiving through manufacturing and final disposition.
- Enforce Good Documentation Practices across inspection records, batch records, travelers, RI/DAI records, and disposition documentation.
- Ensure work orders, travelers, and batch records are executed in compliance with approved procedures and instructions.
- Own the review, verification, and acceptance of manufacturing batch records and travelers before lot release or handoff.
- Verify that required inspection results, testing reports, in-process checks, deviations, nonconformances, and Material Review Board dispositions are documented and approved within the batch record or traveler.
- Ensure traceability is complete and intact, including material lots, subassemblies, equipment identification, and inspection status.
- Identify documentation errors, omissions, or trends during batch record review and ensure timely correction, escalation, and retraining as needed.
- Partner with Manufacturing and Quality Engineering to improve batch record clarity, usability, and execution robustness.
- Oversee Receiving Inspection and First Article Inspection activities according to approved sampling plans and inspection criteria.
- Ensure accuracy, completeness, and traceability of Receiving Inspection and First Article Inspection records, including lot identification and acceptance status.
- Collaborate with Supplier Quality to escalate and document supplier-related quality issues.
- Support calibration and preventive maintenance programs for inspection and manufacturing equipment used for product acceptance.
- Ensure equipment is calibrated, maintained, and suitable for its intended use before release for production or inspection.
- Support corrective maintenance by ensuring quality impact assessments are completed, documentation is updated, and effectiveness is verified after repairs or failures.
- Ensure Quality Control operations comply with ISO 13485, Quality System Regulation/FDA 21 CFR 820, applicable internal Standard Operating Procedures, DOPs, and work instructions.
- Support internal audits, external audits, and regulatory inspections by demonstrating effective Quality Control execution and control.
- Monitor Quality Control metrics and trends to identify compliance risks and improvement opportunities.
- Own continuous improvement initiatives within Quality Control, including monthly Gemba walks focused on inspection effectiveness, material flow, documentation quality, and compliance.
- Use data, observations, and team feedback to identify systemic gaps and drive sustainable improvements.
- Partner with cross-functional teams to implement corrective and preventive improvements.
- A master's degree is preferred.
- Experience managing multiple priorities, balancing production demands with compliance, and operating effectively in a fast-paced manufacturing environment.
- Experience coaching and developing Quality Control inspectors and quality personnel.
- Experience providing training, mentoring, and development to strengthen inspection capability and consistency.
iRhythm Technologies develops cardiac monitoring technology centered on the Zio Patch, a wearable device that records heart rhythms for up to 14 days. The patch is worn by patients to collect continuous heart data, which iRhythm analyzes and interprets to provide diagnostic insights to clinicians without frequent in-person visits. Compared with rivals, the Zio Patch focuses on long-duration, non-intrusive monitoring combined with integrated data analysis that supports telehealth and clinician workflows. Its goal is to improve arrhythmia detection and diagnostic accuracy while streamlining patient care through scalable wearable monitoring and data interpretation.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
San Francisco, California
Founded
2006
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Simplify's Take
What believers are saying
- Extended monitoring improves detection of arrhythmias missed by shorter tests.
- First-quarter revenue reached $199.4 million, up 25.7% year over year.
- Demand can expand through cardiology, primary care, and telehealth referral channels.
What critics are saying
- The June 2026 breach exposed patient PHI and proprietary data.
- Repeated social-engineering attacks on third-party applications remain a persistent exposure.
- A future Zio systems compromise could trigger recalls, inspections, or service disruption.
What makes iRhythm Technologies unique
- Zio combines wearable ECG capture with cloud-based analysis and physician-ready reporting.
- It records continuous heart rhythm data for up to 14 days.
- iRhythm sells an end-to-end diagnostic service, not just a device.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Paid Vacation
Paid Holidays
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Mental Health Support
Hybrid Work Options
Pet Insurance
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 0%Cardiac patients' medical data stolen and held to ransom. Cardiac monitoring provider iRhythm has been hit by a data theft followed by an extortion attempt. In a filing with the Securities and Exchange Commission (SEC), iRhythm revealed it was contacted by someone on June 9 who claimed to have stolen sensitive information, including proprietary data, patient PHI, and other personal information. That person demanded payment in exchange for not publishing the data. iRhythm provides ambulatory cardiac monitoring and analysis (for example using the Zio patch) and has reportedly processed over two billion hours of heartbeat data from more than twelve million patients. In the filing, the company said the data was obtained through social engineering and is from "certain third-party-hosted business applications", without revealing any further details about the amount of data. On its own website, iRhythm also doesn't disclose much about the nature of the stolen data, but does seem to imply no financial data was affected: "Malwarebytes Inc. has not identified any impact to its products, its clinical or medical device systems, its connections to customers, its manufacturing and distribution operations, patient safety, or its ability to meet patient needs. In addition, Malwarebytes Inc. do not store or retain individual financial account information or payment card information. As Malwarebytes Inc. actively investigate, Malwarebytes Inc. will notify individuals affected by this incident in accordance with applicable law and take steps as needed to protect and remediate the impact to them." However, the SEC filing adds that iRhythm determined that the incident is significant, "in light of the volume of the potentially affected data." Together with the extortionist's claims that they have patients' medical data, that makes the breach one worth noting if you have used iRhythm's services. Even without payment data, healthcare breaches have serious downstream effects: * Attackers can craft highly convincing emails, texts, or calls that reference specific procedures or monitoring episodes (for example, "about your recent Zio patch recording") to trick patients into sharing more data or paying fake bills. * The breached data can be used to create a fake identity, insurance fraud, or medical identity theft. * Exposure of cardiac and other health-related information can be deeply sensitive and may have employment/insurance ramifications, especially if data is posted publicly or sold to data brokers. Healthcare breach data tends to circulate for years, and victims may face sporadic fraud and phishing attempts long after the headlines fade. How to stay safe. If you've used iRhythm's services, keep an eye on your post, email, and patient portals for official breach notifications from iRhythm or your healthcare provider. In the US, breaches of protected health information that meet certain criteria must be reported to patients and regulators. iRhythm has promised to "notify individuals affected by this incident in accordance with applicable law and take steps as needed to protect and remediate the impact to them." To stay out of the hands of phishers and scammers: * When you receive a communication about the data breach, verify through other channels that it really came from iRhythm. Go directly to iRhythm's official website or patient portal, or call a known phone number to confirm the communication is genuine. * Be extra suspicious of emails or texts that claim to offer compensation, refunds, or other financial consequences related to this incident. * Change passwords for your iRhythm-linked portals and your cardiology or hospital patient portals, especially if you reused those passwords elsewhere. * Log into your health insurer's portal and check claims on a regular basis. * If you see anything suspicious, report it immediately to your insurer and provider and ask them to flag your account for possible identity theft. * Do not provide personal or financial information over the phone just because the caller knows details about you which they may have obtained from the stolen data. Let's face it, an incognito window can only do so much. Breaches, dark web trading, credit fraud. Malwarebytes Identity Theft Protection monitors for all of it, alerts you fast, and comes with identity theft insurance. Malware Intelligence Researcher Was a Microsoft MVP in consumer security for 12 years running. Can speak four languages. Smells of rich mahogany and leather-bound books.
iRhythm Holdings has gained 9% year-to-date, buoyed by strong volume-led growth across channels and expanding presence in primary care. The ambulatory cardiac monitoring company posted 27% year-over-year revenue growth in fourth-quarter 2025, marking its fifth consecutive quarter exceeding 20% growth. The company now serves approximately 40,000 primary care physicians, with over one-third of total volume coming from these settings. Its deep integration with electronic health record systems and investments in AI-powered diagnostics strengthen its competitive position. iRhythm guides for 2026 revenues of $870-880 million, representing 16%-18% growth. However, the Zacks Rank #3 (Hold) company faces challenges from reimbursement pressures, regulatory headwinds and intensifying competition in cardiac monitoring technologies. Shares trade at a market capitalisation of $3.69 billion.
iRhythm Holdings presented data at the American College of Cardiology 2026 Annual Scientific Sessions demonstrating high prevalence of clinically actionable arrhythmias across cardiovascular-kidney-metabolic patient populations using its Zio ambulatory ECG portfolio. Two retrospective analyses found that 48% of patients with chronic kidney disease and 47% of those with both diabetes and CKD had clinically actionable arrhythmias, compared with 35% of patients with neither condition. A separate study showed patients with severe obesity had nearly threefold higher odds of atrial fibrillation detection compared with normal-weight patients. The company also launched iRhythm Academy, a digital education platform for healthcare professionals. Chief Medical Officer Mintu Turakhia delivered the Louis F. Bishop Keynote on scaling AI in cardiology, emphasising the need to integrate AI into clinical workflows.
iRhythm Technologies reported Q4 revenues of $208.9 million, up 27.1% year-on-year and exceeding analysts' expectations by 3.4%. The cardiac monitoring device maker also beat earnings per share estimates, delivering the strongest analyst beat and highest full-year guidance raise among patient monitoring companies. Despite the strong results, iRhythm's shares have fallen 25.7% since reporting, currently trading at $118.09. The decline suggests investor expectations exceeded Wall Street's published projections. The patient monitoring sector overall reported solid Q4 results, with the four tracked companies beating revenue consensus estimates by 1.9% on average. However, next quarter's revenue guidance came in 1.8% below expectations, and share prices have declined an average of 10.5% following earnings announcements.
iRhythm Holdings has appointed Jason Patten to its Board of Directors, effective 12 March 2026. Patten currently serves as Executive Vice President and Head of Enterprise Strategy at UnitedHealth Group, where he leads corporate strategy, strategic partnerships and innovation functions. The appointment comes as iRhythm, a digital healthcare company specialising in disease detection and prevention, seeks to expand from episodic detection to proactive, integrated care. Chairman Abhi Talwalkar said Patten's experience leading strategy at one of the world's largest healthcare organisations will support the company's growth across primary care, AI capabilities and multiple markets. Patten previously held positions including Chief Operating Officer at OptumHealth and worked in financial services at MoneyGram International and Carlson Marketing Group.