Demo

Quality Training Compliance Specialist

INTELLECTT INC
Scarborough, ME Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/24/2025

Title : Quality Training Compliance Specialist

Location : Scarborough, ME

Key Responsibilities

  • Administer and manage the Learning Management System (LMS) to ensure employees receive necessary training.
  • Provide subject matter expertise on learning processes and systems across functional areas.
  • Facilitate communication, monitoring, and promotion of training activities.
  • Collaborate with Division, Managers, and Team Leaders to enhance learning processes.
  • Establish and maintain proactive relationships with internal and external stakeholders to anticipate and address training needs.
  • Author and review training documentation and materials.
  • Support audit readiness to ensure successful inspection results related to training programs.
  • Ensure training programs meet quality and regulatory standards, including cGMP requirements.
  • Maintain administrative procedures and policies to ensure compliance with business and regulatory expectations.
  • Conduct training curriculum reviews and update training plans accordingly.
  • Develop and coordinate training materials and resources (e.g., presenters, course materials, training space).
  • Create and manage a qualified “train-the-trainer” program.

Basic Qualifications

  • Bachelor's degree in Education, Science, Engineering, Human Resources, Business, Instructional Design, or a related field, or an equivalent combination of education and experience.
  • 2–5 years of experience in the medical device or regulated industry preferred.
  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Preferred Qualifications

  • Knowledge of federal and regulatory requirements, including QSRs, ISO 13485, CMDR, and IVDD / IVDR.
  • Familiarity with adult learning principles and training delivery techniques.
  • Strategic thinking with the ability to balance short-term and long-term training objectives.
  • Strong written and verbal communication skills.
  • Excellent organizational and time management skills, with the ability to manage multiple projects.
  • Experience interacting with regulatory agencies and understanding training compliance requirements.
  • Ability to work independently with minimal supervision.
  • Experience developing and delivering presentations.
  • Knowledge of training documentation requirements for regulatory compliance.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
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