JOB SUMMARY:
Responsible for adjusting production machinery, testing to correct faults, light mechanical repairs and carry out preventive maintenance. Responsible for the operation of the production line, including the initiation of proactive and corrective actions to ensure the quality of the products and the constant flow of products, following the corresponding operating procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Adjust the equipment to achieve the expected levels of quality and productivity, as well as carry out light mechanical repairs to keep the equipment in optimum operation.
2. You are responsible for the final product and its quality, accomplish the quantity and quality goals of established products.
3. Handling materials and supplies, as well as Work in Process.
4. Document in the various documents that integrate the product manufacture and in the device history record (DHR).
5. Knowledge of requirements and quality standards of the manufacturing process of surgical knives.
6. Must be able to detects and evaluate production deviation from standards.
7. You should report any unusual circumstances to the appropriate supervisory staff.
8. Must keep your work area clean and organized.
9. It is required that the Operator is involved and participation in the activities of the work team to provide solutions to: quality problem, productivity problems, Safety Hazards issues and implement corrective actions as necessary.
10. Execute assigned tasks and perform their operator functions in compliance with standards.
11. Execute required preventive maintenance based on established plans
12. Do your work by following OSHA, QSR and ISO standards.
13. The coordination with the Area Supervisor is necessary to ensure the constant flow of products in the production line.
14. You will perform dual functions of customer and supplier in the execution of their functions. As a customer, you must ensure that the materials and products on which you are going to work are of acceptable quality, per the established guidelines. As a supplier, you must ensure that the manufactured product meets the specifications before moving the product to the next production stage.
15. Comply with local, state, and federal regulations, as well as company GMP, and responsibly apply all Company Quality Principles.
16. Provide direction and necessary training to other employees of the Manufacturing Department through a defined training program aimed at increasing their skill levels and preparing them so that they can train other employees. Must be available to work in the areas and shifts required by the company, which will be established per the needs of the company. This includes the possibility of working overtime and / or weekends.
17. The Set-Up is required to participate in work teams related to the execution of projects. This participation will be designed by the supervisor and / or the management and the application only by the selected operators.
18. In occasions, you could you could execute tasks of support to other Departments, as well as execute tasks of Operator, which will be established per the itinerary of work of the Area.
19. Other related duties as assigned by Immediate Supervisor.
LEADERSHIP RESPONSIBILITIES:
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
- Preferred an Associate Degree in Industrial Mechanics or Electromechanical or a minimum of High School Diploma, and/or,
- Two (2) years of previous experience as operator, set-up or mechanic in the Medical Device Manufacturing industry or in any Food, Cosmetics or Pharmaceutical Manufacturing facility.
- Must be able to work 1st, 2nd and 3rd Shift.
At Aspen Surgical, we strive to build a diverse work force through equal opportunity employment that embraces and leverages the differences that each individual has to offer. This job description is only a summary of the typical functions of the job and not intended to be an exhaustive list of all job responsibilities, tasks, and duties. Aspen Surgical Products, Inc. is an equal opportunity Employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.
