Quality Control Lead at iRhythm Technologies

California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Knowledge of GMP, Good Documentation Practices (GDP), and quality system procedures
Experience with Device History Record (DHR) review, Receiving Inspection (RI), calibration, and preventive maintenance (PM) audits
Ability to perform physical inspections, labeling, and QAD transactions
Familiarity with inventory reconciliation, MRB (Material Review Board) processes, and non-conforming material investigations
Skills in conducting Gemba walks, monitoring compliance, cleanliness, and material segregation
Understanding of quality metrics and KPIs (e.g., RI Throughput, Right First Time (RFT), Calibration Compliance Rate, PM Compliance, NC Trending, Inspection Lead Time)
Ability to interface with manufacturing, materials, engineering, and quality teams
Audit readiness and support capabilities, including record retrieval and preparation

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 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 departmental metrics and KPIs: RI Throughput, Right First Time (RFT), Calibration Compliance Rate, Preventive Maintenance (PM) Compliance, NC Trending Metrics, Inspection Lead Time
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

Skills

GMP

DHR Review

Receiving Inspection

Calibration Audit

Preventive Maintenance

Quality Audits

Inspections

Quality Metrics

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