Training Specialist (Operations/Quality/Manufacturing)

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This position within the Manufacturing Engineering Department will be responsible for developing and facilitating all aspects of visual inspection training and assessments. The primary objective will be to ensure that the manufacturing and quality teams possess the necessary skills and knowledge to perform visual inspections effectively and efficiently, thereby maintaining the highest quality standards for our products. Additionally, this position will support general training coordination to assist the manufacturing team with facilitating execution of training in a compliant, efficient, and timely manner.

The purpose of this position is to coordinate the medical and skin KTA (Knowledge Transfer Assessment) programs for operator/quality inspection groups defect recognition and expertise, which is critical to the business to reduce scrap and improve yields. This individual will also support the Engineering and Manufacturing teams coordinate overall training for projects, deviations, and change controls. This will create bandwidth for the engineers in the group to support more technical needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Training Program Development:

• 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.

Training Coordination:

• 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.

Training Delivery:

• Provide clear instructions on visual inspection techniques, defect identification, and evaluation criteria.

• Address trainees' questions, concerns, and feedback during and after the training sessions.

Skill Assessments:

• 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.

Continuous Improvement:

• Monitor the effectiveness of training programs and make recommendations for continuous improvement.

• Seek feedback from trainees and stakeholders to enhance the training process continually.

Compliance and Documentation:

• 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.

Team Collaboration:

• 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.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor’s degree

• 3+ years of experience in regulated manufacturing environment, preferably in 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.