PURPOSE OF JOB

Train operational personnel both in the theoretical and practical part of reference to the production lines, to certify the collaborators in the different operations of each line. Keep track and record of training in the program required by the company. Provide support to the production lines in technical aspects that are necessary, as well as flexibility in any other task that their position warrants. Support in the resolution of non-conformities or CAPAs as well as in their investigation process if necessary. Carry out the quality performance, whether it is the start, process or final, at the times that the quality department so warrants.

RESPONSABILITIES

• Theoretical training of staff.
• Qualification of operational personnel in previously assigned areas.
• Keep the training system up to date.
• Support the production department in solving problems.
• Develop procedures that will be used to ensure product quality and process capability.
• Review procedures to ensure accuracy and make required updates through Documentation change control.
• Work with Production and other Departments to develop procedures to ensure product quality.
• Perform quality inspections whether start, process or final.
• Performs other functions as required.
• Continuous improvement of the training system.
• Coordination for conducting environmental monitoring.
• Coordination of equipment calibration.

REQUIREMENTS

EDUCATION:  

• High School Diploma
• Quality technician/supervision is preferred or proven experience failing that.

ADDITIONAL SKILLS:

• Knowledge in Microsoft Office.
• Knowledge of FDA regulations, Quality System Regulations (QSR) work, ISO 13485.
• Ability to work effectively in a medium-sized organization.
• English B1/B2
• Teamwork