Quality System Training Lead

3 weeks ago

Metro Manila Philippines iRhythm Technologies, Inc. Full time

Overview

The Quality System Training Lead is responsible for managing and implementing the process associated with the training of iRhythm employees across multiple sites to maintain compliance to processes and standards.

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
  • 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 initiative and contribute to a culture of compliance and continuous improvement
  • Perform other quality and regulatory-related duties as assigned
Required Qualifications
  • Strong communication (verbal and written), presentation and interpersonal skills
  • Attention to detail and timeliness are critical
  • Software proficiency in Microsoft Office Suite is required and experience working in a Learning Management System (LMS) strongly preferred
  • Familiarity with e-learning development tools (Articulate, Captivate, etc.)
  • Must build rapport across functional teams within the organization
  • Bachelor’s Degree or equivalent experience
  • Minimum of 4 years of training experience at a regulated industry
  • Must operate through collaboration and transparency
  • Experience in cGMP/GDP/GCP environments and FDA QSR and ISO13485 regulated industries is preferred

This is a full time position. We offer an excellent benefit and salary package.

Location: Pasig, National Capital Region, Philippines

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Training and Quality Assurance

Industries

Medical Equipment Manufacturing

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