Quality Control Lead

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

Boldly innovating to create trusted solutions that detect, predict, and prevent disease.

Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now!

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm's employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.

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.

• 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.

• 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.

• 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.

• 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!