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Quality Assurance Training Compliance Coordinator

2 months ago

Scarborough, Maine, United States SMS Staffing Inc. Full time
Position Overview

SMS Staffing Inc. is actively seeking a dedicated Quality Assurance Training Compliance Coordinator.

Job Title:

Quality Assurance Training Compliance Coordinator

Job Type:

Contract (with potential for extension or conversion to permanent)

Compensation:

Starting at $30.00 per hour

Work Schedule:

ONSITE, 8:00 PM - 5:00 PM, Monday to Friday, 40 hours per week

Role Responsibilities:

The Quality Assurance Training Compliance Coordinator plays a vital role in providing training support and expertise to ensure adherence to the Quality System and effective management of the Learning Management System. Key responsibilities include:

  • Offering Subject Matter Expertise on the learning process and Learning Management System to various functional areas.
  • Facilitating effective communication, monitoring, and promotion of learning initiatives.
  • Collaborating with Division Managers and Team Leaders to enhance learning processes and systems.
  • Building and maintaining proactive relationships with internal and external stakeholders, understanding customer needs, and addressing issues promptly.
  • Creating and reviewing training documentation and materials.
  • Supporting audit readiness to achieve successful inspection outcomes related to the Learning System and processes.
  • Ensuring training programs meet established quality standards.
  • Coordinating and supporting the completion of training programs necessary for compliance with cGMP requirements.
  • Maintaining administrative procedures and policies to align with business processes and regulatory expectations.
  • Conducting reviews of training curricula and updating training plans as needed.
  • Assisting in the development of training materials.
  • Coordinating resources such as presenters, course materials, and training spaces.
  • Creating and managing a qualified 'train the trainer' program.
Candidate Profile:

The ideal candidate will possess the following qualifications:

  • A 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 is preferred.
  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Familiarity with federal regulations, including QSR's, ISO 13485, CMDR, IVDD/IVDR.
  • Understanding of adult learning principles and delivery techniques is advantageous.
  • Strategic thinking capabilities with the ability to balance short-term and long-term objectives effectively.
  • Experience in preparing and delivering presentations.
  • Strong written and verbal communication skills are essential.
  • Excellent organizational and time management skills, with the ability to prioritize multiple tasks.
  • Ability to interact appropriately with regulatory agencies.
  • Working knowledge of training requirements set by regulatory bodies.
  • Ability to work independently with minimal supervision.
  • Commitment to following standard safety policies and procedures.

Join the SMS team and contribute to our mission of delivering exceptional service and quality to our customers. We value individuals who are dedicated to excellence and willing to go the extra mile to achieve success.