Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
Ensure inspectors are trained, qualified to perform inspections and documentation per approved procedures.
Establish clear expectations and accountability for inspection accuracy, documentation integrity, and timely escalation of quality issues.
Inspection Strategy & Manufacturing Quality Support
Support the development, implementation, and continuous improvement of inspection plans, sampling strategies, and control plans in collaboration with Quality Engineering, Supplier Quality and Manufacturing Engineering.
Ensure effective in-process, final, and receiving inspections are executed in accordance with approved inspection plans and work instructions.
Drive improvements to inspection efficiency, first-pass yield, and defect containment across manufacturing operations.
Nonconformance, MRB & Planned Deviation Support
Ensure timely identification, documentation, and containment of nonconforming material in manufacturing and receiving.
Support and participate in Material Review Board (MRB) activities, ensuring accurate disposition execution and documentation.
Support planned deviations to maintain production continuity while ensuring risk assessments, approvals, and documentation are completed per the Quality Management System.
Ensure all dispositions, deviations, and containment actions are accurately reflected in work orders, travelers, and batch records.
Material Identification, Traceability & Documentation Control
Ensure proper material identification, segregation, labeling, and traceability from receiving through manufacturing and final disposition.
Enforce Good Documentation Practices (GDP) across inspection records, batch records, travelers, RI/DAI records, and disposition documentation.
Ensure work orders, travelers, and batch records are executed in compliance with approved procedures and instructions.
Batch Record Review
Own the review, verification, and acceptance of manufacturing batch records and travelers to ensure completeness, accuracy, and compliance prior to lot release or handoff.
Verify that all required inspection results, testing reports, in-process checks, deviations, nonconformances, and MRB dispositions are properly documented and approved within the batch record or traveler.
Ensure traceability is complete and intact, including material lots, subassemblies, equipment identification, and inspection status.
Identify documentation errors, omissions, or trends during batch record review and ensure timely correction, escalation, and retraining as necessary.
Partner with Manufacturing and Quality Engineering to improve batch record clarity, usability, and execution robustness.
Receiving Inspection Oversight
Oversee execution of Receiving Inspection and FAI activities per approved sampling plans and inspection criteria.
Ensure accuracy, completeness, and traceability of RI and FAI records, including lot identification and acceptance status.
Collaborate with Supplier Quality to ensure timely escalation and documentation of supplier-related quality issues.
Equipment Control: Calibration, PM & Maintenance Support
Support of calibration and preventive maintenance (PM) programs for inspection and
Benefits
Health insurance
Additional Information
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:
The Quality Control Manager is responsible for leading Quality Control execution across Manufacturing and Receiving operations, ensuring effective inspection, documentation, material control, and disposition activities. This role provides direct leadership to Manufacturing Quality Inspectors and Receiving Inspection teams and owns day-to-day quality control execution on the manufacturing floor.
The Quality Control Manager ensures compliance with applicable regulatory requirements and internal procedures while enabling efficient production through robust inspection plans, effective nonconformance and deviation management, and continuous improvement initiatives.
Why This Role Is Critical
Establishes clear ownership of shop-floor quality execution
Reduces compliance and audit risk related to inspection, documentation, and material control
Enables scalable manufacturing growth while maintaining product quality and regulatory compliance
Strengthens quality culture through visible leadership and continuous improvement
Irhythmtech · Orange County, CA