Setup Operator- Partime

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

• 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.
• Responsible for the final product and its quality, accomplish the quantity and quality goals of established products.
• Handle materials and supplies, as well as Work in Process.
• Document in the various documents that integrate the product manufacture and in the device history record (DHR).
• Knowledge of requirements and quality standards of the manufacturing process of surgical knives.
• Detect and evaluate production deviation from standards and report any unusual circumstances to the appropriate supervisory staff.
• Keep work area clean and organized.
• Participate in work team activities to provide solutions to quality problems, productivity problems, safety hazards issues and implement corrective actions as necessary.
• Execute assigned tasks and perform operator functions in compliance with standards.
• Execute required preventive maintenance based on established plans.
• Work following OSHA, QSR and ISO standards.
• Coordinate with the Area Supervisor to ensure the constant flow of products in the production line.
• Perform dual functions of customer and supplier: ensure materials and products are of acceptable quality, and ensure manufactured product meets specifications before moving to the next production stage.
• Comply with local, state, and federal regulations, as well as company GMP, and apply all Company Quality Principles.
• Provide direction and necessary training to other employees of the Manufacturing Department through a defined training program.
• Be available to work in the areas and shifts required by the company, including the possibility of working overtime and/or weekends.
• Participate in work teams related to the execution of projects.
• Occasionally execute tasks of support to other Departments, as well as execute tasks of Operator, as established per the itinerary of work of the Area.
• Other related duties as assigned by Immediate Supervisor.

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.

Schedule

The schedule for this role is Friday, Saturday, and Sunday, 6:00 PM to 12:00 AM. Candidates must be available to work this weekend shift schedule.