Quality Training Compliance Specialist

Title: Quality Training Compliance SpecialistLocation: Scarborough, ME Key ResponsibilitiesAdminister 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 QualificationsBachelor'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 QualificationsKnowledge of federal and regulatory requirements, including QSRs, ISO 13485, CMDR, and IVDDIVDR.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).

Created: 2025-02-23