iRhythm Technologies, Inc. · 5 hours ago
Quality Control Inspector (2nd Shift)
iRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions to detect, predict, and prevent disease. The 2nd Shift Quality Control Inspector is responsible for supporting manufacturing operations by performing inspections, documentation reviews, and batch release readiness activities for finished goods and sub-assemblies, ensuring compliance with Good Documentation Practices and timely identification of quality issues.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
Perform detailed review of batch records and travelers for finished goods and sub-assemblies to ensure completeness, accuracy, and compliance with approved procedures
Verify that all required manufacturing steps, inspections, testing reports, in-process checks, and approvals are properly completed and documented
Ensure material traceability, including material lots, subassemblies, equipment identification (when applicable), and inspection status
Access and reference the electronic Quality Management System (eQMS) to ensure the current, approved revisions of drawings, specifications, procedures, and work instructions are used during inspection and batch record review activities
Verify that batch records, travelers, and inspection activities are executed against the correct released document revisions, and escalate discrepancies when outdated or incorrect documents are identified
Identify documentation errors, omissions, or discrepancies and ensure timely correction in accordance with GDP requirements
Perform in-process, final, or verification inspections of finished goods and sub-assemblies per approved inspection plans and work instructions
Ensure inspection results are accurately recorded and aligned with acceptance criteria
Support timely review and release readiness of manufacturing lots to maintain production flow
Identify, document, and initiate Nonconformance (NC) records when inspection results, documentation, or material conditions do not meet requirements
Ensure nonconforming material is properly identified, labeled, and segregated to prevent unintended use
Escalate quality issues to Quality Control leadership and Manufacturing supervision as required
Enforce GDP standards across all reviewed records, including batch records, travelers, routers, and inspection forms
Ensure corrections, clarifications, and late entries (when applicable) are performed per approved GDP procedures
Support identification of recurring documentation issues and participate in corrective actions or retraining as needed
Perform Receiving Inspection (RI) activities when required, following approved sampling plans, inspection criteria, and procedures
Verify material identification, lot traceability, and acceptance status
Accurately document RI results and communicate material status to Manufacturing and Quality teams
Perform all activities in compliance with ISO 13485, and internal QMS SOPs, DOP’s and work instructions
Maintain inspection areas and records in a state of audit readiness
Support internal audits and regulatory inspections by providing accurate records and inspection evidence as requested
Communicate inspection results, documentation issues, and open quality concerns clearly during shift handoffs
Collaborate with Manufacturing, Quality Engineering, Receiving, and first-shift QC personnel to ensure continuity of quality controls
Qualification
Required
High School Diploma or GED required
Minimum of 2–5 years of experience in a medical device manufacturing, pharma, aerospace or regulated manufacturing environment, preferably in Quality Control or Inspection
Experience navigating an electronic Quality Management System (eQMS) to review and reference released drawings, specifications, SOPs, and work instructions
Working knowledge of Good Documentation Practices (GDP) and controlled document execution
Experience reviewing batch records, travelers, routers, and inspection records
Ability to identify quality issues and initiate nonconformance records in accordance with established procedures
Strong attention to detail with a focus on accuracy, compliance, and data integrity
Ability to work independently on second shift with minimal supervision
Effective verbal and written communication skills
Ability to manage multiple tasks and prioritize work to support production needs
Preferred
Associate's or Bachelor's Degree in a technical or life sciences field
Experience performing Receiving Inspection (RI) or FAI activities
Familiarity with sampling plans, inspection plans, and acceptance criteria
Demonstrated experience reviewing engineering drawings, including GD&T, to identify critical-to-quality (CTQ) characteristics, specification notes, and applicable inspection requirements, and applying them during inspection and batch record review
Experience using enterprise resource planning (ERP) systems (e.g., QAD, SAP) to support manufacturing execution, batch review, material status, and traceability
Company
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.
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
Recent News
Investor's Business Daily
2026-01-13
2026-01-07
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