Integra Lifesciences Holdings Corporation

posted 2 months ago

Full-time - Mid Level
1,001-5,000 employees
Management of Companies and Enterprises

About the position

The Training Specialist position within the Manufacturing Engineering Department is a pivotal role focused on developing and facilitating comprehensive visual inspection training and assessments. This position is essential for ensuring that both the manufacturing and quality teams are equipped with the necessary skills and knowledge to perform visual inspections effectively and efficiently, thereby upholding the highest quality standards for our products. The primary objective of this role is to coordinate the medical and skin Knowledge Transfer Assessment (KTA) programs for operator and quality inspection groups, which is critical for reducing scrap and improving yields in the manufacturing process. In addition to training program development, the Training Specialist will support general training coordination to assist the manufacturing team in executing training in a compliant, efficient, and timely manner. This includes collaborating with subject matter experts (SMEs) and manufacturing engineers to design tailored training programs, developing training materials, and scheduling training sessions that minimize disruption to production schedules. The role also involves monitoring training attendance, maintaining accurate training records, and ensuring that all training aligns with regulatory requirements and industry standards. The Training Specialist will deliver training sessions, provide clear instructions on visual inspection techniques, and address any questions or concerns from trainees. They will also design and administer assessments to evaluate trainees' comprehension and proficiency, analyze results to identify knowledge gaps, and collaborate with supervisors to implement corrective actions or follow-up training as needed. Continuous improvement is a key focus, as the Training Specialist will monitor the effectiveness of training programs and seek feedback from trainees and stakeholders to enhance the training process continually. Overall, this position plays a crucial role in integrating visual inspection standards into the quality management system and supporting the overall success of the manufacturing operations.

Responsibilities

  • Collaborate with subject matter experts (SMEs) and manufacturing engineers to design comprehensive visual inspection training programs tailored to the specific needs of different production areas.
  • Aid in the development of training materials, presentations, and visual aids to support the training curriculum.
  • Schedule and coordinate visual inspection training sessions for new hires, as well as ongoing training for existing employees.
  • Arrange training sessions to minimize disruption to production schedules.
  • Monitor training attendance and maintain accurate training records for all employees.
  • Assist Manufacturing Engineering and Operations with coordination of other trainings, including SOP updates and awareness training.
  • Provide clear instructions on visual inspection techniques, defect identification, and evaluation criteria.
  • Address trainees' questions, concerns, and feedback during and after the training sessions.
  • Design and administer visual inspection assessments to evaluate trainees' comprehension and proficiency.
  • Analyze assessment results to identify knowledge gaps and areas for improvement.
  • Collaborate with supervisors and managers to implement corrective actions or follow-up training as needed.
  • Monitor the effectiveness of training programs and make recommendations for continuous improvement.
  • Seek feedback from trainees and stakeholders to enhance the training process continually.
  • Ensure that the visual inspection training program aligns with regulatory requirements and industry standards.
  • Maintain accurate and up-to-date training documentation, including training records and assessments results.
  • Work closely with the Manufacturing Engineering and Site Quality teams to integrate visual inspection standards into the overall quality management system.
  • Collaborate with production supervisors and managers to identify specific training needs and address performance issues related to visual inspection.

Requirements

  • Bachelor's degree
  • 3+ years of experience in a regulated manufacturing environment, preferably in the medical device or pharmaceutical industry.
  • Strong understanding of visual inspection techniques, defect identification, and quality assurance principles.
  • Knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.
  • Excellent communication and presentation skills.
  • Ability to work collaboratively with cross-functional teams and adapt to different learning styles.
  • Detail-oriented with strong organizational and documentation skills.
  • Strong proficiency in Microsoft Excel (intermediate or higher), Word, and PowerPoint.
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