• Job Tag: #LI-KF1
• Posted: August 21,2024

About Us: Our client is a leading innovator in the medical device industry dedicated to advancing patient care through high-quality products and services. Their commitment to excellence is reflected in our rigorous quality standards and continuous improvement efforts. We are seeking a highly skilled Quality Systems Trainer to join our team and drive our training initiatives to support our quality goals.

Job Summary: The Quality Systems Engineer will play a crucial role in designing, developing, and delivering training programs that ensure our quality systems are effectively communicated and practiced throughout the organization. This role demands expertise in quality management systems and a talent for creating engaging, educational content that meets the needs of a diverse audience.

Key Responsibilities:
 

1. Curriculum Development:
   • Develop and maintain training programs focused on quality management systems (QMS), regulatory compliance, and industry best practices specific to the medical device sector.
   • Create a range of instructional materials, including manuals, e-learning modules, presentations, and interactive exercises, ensuring they are aligned with industry standards and organizational policies.
   • Regularly update training content to reflect changes in regulations, industry trends, and company procedures.
2. Training Delivery:
   • Lead training sessions for employees at all levels, including new hire orientation, ongoing education, and specialized training for different roles.
   • Utilize various instructional methods such as classroom training, virtual sessions, workshops, and hands-on simulations to effectively engage learners.
   • Assess the effectiveness of training programs through participant feedback, performance metrics, and other evaluation tools, and adjust programs as needed.
3. Quality Systems Expertise:
   • Stay informed about industry developments, regulatory changes, and best practices in quality management.
   • Serve as a subject matter expert, providing support and guidance on quality system-related issues across the organization.
   • Collaborate with cross-functional teams to ensure training programs align with quality objectives and regulatory requirements.
4. Continuous Improvement:
   • Monitor and evaluate the impact of training programs on quality performance and compliance, identifying opportunities for enhancement.
   • Contribute to the development and maintenance of quality system documentation, including SOPs, work instructions, and quality manuals.
   • Support the implementation of new quality initiatives and ensure they are effectively communicated through training programs.
5. Reporting and Documentation:
   • Maintain detailed records of training activities, participant progress, and outcomes.
   • Prepare reports on training effectiveness, program metrics, and improvement recommendations.
   • Ensure that all training documentation is accurate, complete, and accessible.

Qualifications:
 

• Bachelor’s degree in Quality Management, Engineering, Life Sciences, or a related field. Advanced degree or relevant certifications (e.g., Six Sigma, ISO 13485) preferred.
• 5+ years of experience in quality systems, curriculum development, and/or training, ideally within the medical device or regulated industry.
• Strong knowledge of quality management principles, regulatory standards (e.g., FDA, ISO), and industry best practices.
• Proven experience in designing and delivering effective training programs and materials.
• Excellent communication, presentation, and interpersonal skills.
• Strong analytical skills with attention to detail and the ability to simplify complex information.
• Proficiency in e-learning platforms, Learning Management Systems (LMS), and Microsoft Office Suite.
• Exceptional organizational skills with the ability to manage multiple projects and meet deadlines.