Quality Control Lead - Onsite

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. What’s 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, iRhythm’s 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.

Created: 2025-10-02