Sr. Quality Engineer - 2nd Shift at iRhythm Technologies

United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related technical field (required); Master’s degree is a plus
5–8 years of experience in medical device manufacturing quality engineering or similar regulated industry
Deep knowledge of FDA QSR (21 CFR 820), ISO 13485, and EU MDR compliance
Experience with non-conformance management, CAPA, validation protocols, and change control processes
Skilled in problem-solving methodologies (8D, DMAIC, 5-Whys) and use of statistical tools (e.g., Minitab)
Familiarity with ISO 14971 risk management and statistical sampling approaches (e.g., AQL)
Effective communicator with ability to work independently and cross-functionally on the second shift
Highly organized and responsive to shift-based needs and priorities
Preferred Skills
Experience with ERP and eQMS systems (e.g., QAD, Master Control)
Prior audit support experience with FDA or Notified Bodies
Quality certifications (e.g., CQE, Six Sigma Green/Black Belt) are a plus

Responsibilities

Serve as second-shift quality owner for non-conformance (NCR), material review board (MRB), and batch record review activities within manufacturing and intake
Provide real-time quality support to operations, warehouse, and engineering teams during second shift to ensure uninterrupted flow of product and data
Lead or support investigations, root cause analysis, and corrective/preventive action (CAPA) implementation for product and process deviations
Support execution of equipment and process validation (IQ/OQ/PQ) for new or modified equipment and processes occurring during second shift hours
Ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory standards during second-shift activities
Maintain and report key performance indicators (KPIs) for operations quality; identify trends and lead process improvements
Participate in internal/external audits, inspection readiness, and routine walkthroughs to ensure ongoing quality and compliance
Collaborate cross-functionally with production, maintenance, supply chain, and engineering teams during the evening shift

Skills

Non-conformance Investigations

Material Review Board

Batch Record Review

Process Validation

Quality Systems

Manufacturing Operations

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

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

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.

FDA warning letter may lead to regulatory scrutiny and potential fines.

Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.

iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.

The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.

Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.

AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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