Quality Control Inspector (2nd Shift)

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 2nd Shift Quality Control (QC) Inspector is responsible for supporting manufacturing operations during second shift by performing inspection, documentation review, and batch release readiness activities for finished goods and sub-assemblies. This role focuses on reviewing batch records, travelers, and routers, ensuring Good Documentation Practices (GDP) compliance, identifying quality issues, and initiating nonconformances (NCs) when required.

The QC Inspector also provides Receiving Inspection (RI) support as needed to ensure material flow continuity and compliance with inspection requirements.

Why This Role Is Critical

• Provides real-time quality oversight on second shift, ensuring batch records, travelers, and GDP compliance are verified at the time of execution rather than retrospectively.
• Enables timely identification and containment of nonconformances, reducing quality escapes, rework, and compliance risk.
• Supports on-time release readiness and uninterrupted manufacturing flow, preventing inspection and documentation backlogs into first shift.
• Strengthens audit readiness and cross-shift continuity, ensuring clear handoff and sustained control of quality issues across shifts.

What You WIll Be Doing

Batch Record, Traveler & Router Review

• 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.

Finished Goods & Sub-Assembly Inspection

• 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.

Nonconformance Identification & Escalation

• 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.

Good Documentation Practices (GDP) Compliance

• 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.

Receiving Inspection (RI) Support

• 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.

Compliance & Audit Readiness

• 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.

Cross-Shift & Cross-Functional Communication

• 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.

What We Want to See

• High School Diploma or GED required; Associate's or Bachelor's Degree in a technical or life sciences field is preferred.
• 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.

Ways to Stand Out

• 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 is a plus

Location:

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

Estimated Pay Range

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. 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.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121