Quality System Training Lead at iRhythm Technologies

Manila, Metro Manila, Philippines

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Strong communication (verbal and written), presentation and interpersonal skills
Attention to detail and timeliness
Software proficiency in Microsoft Office Suite
Experience working in a Learning Management System (LMS) strongly preferred
Familiarity with e-learning development tools (Articulate, Captivate, etc.)
Ability to build rapport across functional teams
Bachelor’s Degree or equivalent experience
Minimum of 4 years of training experience at a regulated industry
Ability to operate through collaboration and transparency
Experience in cGMP/GDP/GCP environments and FDA QSR and ISO 13485 regulated industries preferred

Responsibilities

Maintenance and continuous improvement of the training process at iRhythm
Identify and assign training based on employee training plans
Coordinate and perform online and live training
Evaluate training effectiveness
Management and maintenance of Quality System training requirements and records
Management and maintenance of training in the electronic system
Collaborate cross-functionally to complete responsibilities across multiple iRhythm sites
Support external/internal audits and inspections for training records and processes
Prepare training reports and metrics
Develop and implement training courses
Provide feedback and collaborate with subject matter experts (SME) on creation of training material
Ensure compliance with FDA 21 CFR 820.25, ISO 13485 and other applicable standards
Assess the effectiveness of training through evaluations, testing and performance testing
Participate in company quality initiatives and contribute to a culture of compliance and continuous improvement
Perform other quality and regulatory-related duties as assigned

Skills

QMS

Training Management

Compliance

Audit Support

Learning Management System

Metrics Reporting

Cross-Functional Collaboration

Course Development

Training Evaluation

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Mental Health Support

Hybrid Work Options

Pet Insurance

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.

FDA warning letter may lead to regulatory scrutiny and potential fines.

Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.

iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.

The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.

Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.

AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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