iRhythm Technologies, Inc. · 21 hours ago
Quality Control Manager
Orange County, CA
Full-time
Onsite
Senior Level, Lead/Staff
$112K/yr - $145K/yr
8+ years expiRhythm Technologies, Inc. is a leading digital healthcare company focused on cardiac health solutions. The Quality Control Manager will oversee quality control execution across manufacturing and receiving operations, ensuring compliance with regulatory requirements and effective inspection processes.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
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
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
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
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
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
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
Support of calibration and preventive maintenance (PM) programs for inspection and manufacturing equipment used for product acceptance
Ensure equipment is calibrated, maintained, and suitable for its intended use prior to release for production or inspection
Support corrective maintenance activities by ensuring quality impact assessments are completed, documentation is updated, and effectiveness is verified following repairs or failures
Ensure QC operations comply with ISO 13485, QSMR/FDA 21 CFR 820 and applicable internal SOPs, DOP’s and work instructions
Support internal audits, external audits, and regulatory inspections by demonstrating effective QC execution and control
Monitor QC-related metrics and trends to proactively identify compliance risks and improvement opportunities
Own continuous improvement initiatives within Quality Control, including monthly Gemba walks focused on inspection effectiveness, material flow, documentation quality, and compliance
Use data, observations, and team feedback to identify systemic gaps and drive sustainable improvements
Partner with cross-functional teams to implement corrective and preventive improvements
Qualification
Required
Bachelor's Degree in Life Sciences, Engineering, or a related technical discipline is required
Minimum of 8 years of progressive experience in a medical device manufacturing environment, with demonstrated responsibility for quality control, inspection, or manufacturing quality operations
Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820, with working familiarity of EU MDD and EU MDR requirements
Demonstrated ability to identify, investigate, and resolve complex quality and manufacturing issues, including nonconformances, MRB activities, deviations, and corrective actions
Proven experience collaborating with Manufacturing, Quality Engineering, Supplier Quality, Engineering, Operations, and Facilities/Maintenance teams
High level of attention to detail, with strong focus on timeliness, data accuracy, and GDP compliance
Excellent verbal and written communication skills, with the ability to communicate expectations, risks, and decisions at all organizational levels
Working knowledge of statistical and quality tools, including trend analysis, process capability (Cp/Cpk, Pp/Ppk), Gage R&R, and defect trend analysis
Working knowledge of medical device risk management, including process FMEAs and alignment with ISO 14971 principles
Preferred
Master's Degree is preferred
Highly organized, with the ability to manage multiple priorities, balance production demands with compliance, and operate effectively in a fast-paced manufacturing environment
Demonstrated leadership style that is empathetic, collaborative, and accountability-driven, with experience coaching and developing QC inspectors and quality personnel
Experience providing training, mentoring, and development to strengthen inspection capability and consistency
Company
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.
1001-5000 employees
H1B Sponsorship
iRhythm Technologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (10)
2022 (9)
2021 (16)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$1.18BKey Investors
BraidwellNovo HoldingsNorwest
2024-03-04Post Ipo Debt· $643.6M
2020-08-21Post Ipo Secondary· $220M
2019-09-11Post Ipo Equity· $115M
Leadership Team
Quentin Blackford
Chief Executive Officer
Mark Day
Chief Technology Officer
Recent News
2026-01-16
Investor's Business Daily
2026-01-13
Company data provided by crunchbase