iRhythm Technologies, Inc. · 2 weeks ago
Quality Control Lead
Orange County, CA
Full-time
Onsite
Senior Level
$28.85/hr - $36.06/hr
5+ years expiRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. The Quality Control Lead will support the execution of critical quality activities, ensuring compliance with quality system procedures and driving operational excellence by contributing to quality metrics and performing hands-on inspections.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
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
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
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
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
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
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
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
Qualification
Required
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
Benefits
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
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
PTO
401(k) (with company match)
Employee Stock Purchase Plan
Pet insurance discount
Unlimited amount of LinkedIn Learning classes
Company
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.
1001-5000 employees
H1B Sponsorship
iRhythm Technologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (10)
2022 (9)
2021 (16)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$1.18BKey Investors
BraidwellNovo HoldingsNorwest
2024-03-04Post Ipo Debt· $643.6M
2020-08-21Post Ipo Secondary· $220M
2019-09-11Post Ipo Equity· $115M
Leadership Team
Quentin Blackford
Chief Executive Officer
Mark Day
Chief Technology Officer
Recent News
2026-01-07
GlobeNewswire
2025-12-08
Company data provided by crunchbase