Quality Control Lead

About This Role

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.

• 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, Right First Time (RFT), Calibration Compliance Rate, PM Compliance, NC Trending Metrics, and Inspection Lead Time.

• 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 and contribute to process standardization. Maintain a collaborative and supportive work environment.

• 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.

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, and access to Linked In Learning classes. FLSA Status:
Nonexempt

As a part of our core values, we ensure a diverse and inclusive workforce. 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. We provide reasonable accommodations for qualified individuals with disabilities in job application procedures. If you need such an accommodation, contact

Location:

Orange County

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range: $28.85 - $36.06