Quality Control Lead - Onsite (Orange County)

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

Floor Audits & Compliance Monitoring

Quality Metrics and KPIs

Operational Support

Audit Readiness & Support

Team & Continuous Improvement

About you :

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 :

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 taops@irhythmtech.com

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.