Quality Control Lead

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:

Boldly innovating to create trusted solutions that detect predict and prevent disease.

Discover your power to innovate while making a difference in patients is advancing cardiac careJoin Us Now!

At iRhythm we are dedicated self-motivated and driven to do the right thing for our patients clinicians and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together embrace change and help one another. We are Thinking Bigger and Moving Faster.

About this role:

The Quality Control Lead will support the execution of critical quality activities including Device History Record (DHR) review Receiving Inspection (RI) and calibration/preventive maintenance record audits. This role ensures compliance with quality system procedures and drives operational excellence by contributing to quality metrics supporting audits and performing hands-on inspections as needed.

Key Responsibilities:

Documentation Review & Records Management

• Review and approve Device History Records (DHRs) for sub-assemblies and Finished Goods (FG) to ensure compliance with GMP and procedural requirements.

• Review and approve RI documentation for completeness and traceability prior to material release.

• Audit calibration and PM records to ensure documentation accuracy and equipment qualification compliance.

• Maintain records in alignment with Good Documentation Practices (GDP) and submit them for document control archival.

Receiving Inspection & Inventory Support

• Assist RI team with incoming inspection of raw materials and components as needed to meet throughput targets.

• Perform physical inspection labeling and QAD transactions to release accepted lots.

• Perform and reconcile on-hold qualified material inventory.

• Participate in MRB inventory control; reconcile physical inventory vs. system (QAD).

• Initiate and assist in investigations of non-conforming material support segregation quarantine and documentation of disposition.

Floor Audits & Compliance Monitoring

• Conduct routine Gemba walks in production warehouse receiving and MRB to ensure labeling and identification compliance.

• Monitor cleanliness organization and status segregation of materials.

• Support monthly Laboratory Assessments and equipment inventory audits.

Quality Metrics and KPIs

Support and contribute to the following departmental metrics and KPIs:

• RI Throughput Number of lots/materials inspected and released per day/week/month.

• Right First Time (RFT) Percentage of records or inspections completed without rework or error.

• Calibration Compliance Rate Percentage of equipment calibrated on time.

• Preventive Maintenance (PM) Compliance Timeliness of PM activities performed vs. scheduled.

• NC Trending Metrics Number and type of non-conformances raised from DHR/RI/FA audits.

• Inspection Lead Time Average time from material receipt to inspection completion.

Operational Support

• Perform RI and final acceptance inspections based on workload prioritization.

• Interface with manufacturing materials engineering and quality teams to resolve issues and ensure continuous flow.

• Escalate quality risks or systemic issues to leadership in a timely manner.

Audit Readiness & Support

• Retrieve and prepare DHR RI calibration and PM records for internal and external audits.

• Act as audit escort or subject matter resource for inspection-related questions.

Team & Continuous Improvement

• Participate in quality improvement initiatives lean activities and training programs.

• Cross-train on inspection procedures contribute to process standardization.

• Maintain a collaborative and supportive work environment.

About you:

• Minimum 5 years in Medical Device Quality Assurance or equivalent regulated industry.

• Proficient in 21 CFR Part 820 ISO 13485 and GDP/GMP.

• Experience in DHR review receiving inspections and use of basic measurement tools.

• Skilled in Microsoft Excel QAD (or equivalent ERP) and electronic documentation systems.

• Strong attention to detail time management and problem-solving skills.

Whats in it for you:

This is a regular full-time position with competitive compensation package excellent benefits including medical dental and vision insurances (all of which start on your first day) health savings account employer contributions (when enrolled in high deductible medical plan) cafeteria plan pre-taxed benefits (FSA dependent care FSA commute reimbursement accounts) travel reimbursement for medical care noncontributory basic life insurance & short/ long term disability. Additionally we offer:

• emotional health support for you and your loved ones

• legal / financial / identity theft/ pet and child referral assistance

• paid parental leave paid holidays travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match) an Employee Stock Purchase Plan pet insurance discount unlimited amount of LinkedIn Learning classes and so much more!

FLSA Status:Nonexempt

As a part of our core values we ensure a diverse and 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.

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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