Operator - Manufacturing (2nd/3rd shift)

Job Summary

Operator is responsible for the assembly and quality of components in the manufacture of final products  to fulfill the goals of the production team.  Responsible to complete units or subassemblies at a bench, conveyor line, or on the floor. The operator must understand the requirements/procedures through training and practice.  Work may involve the use of hand tool, fixtures and special equipment in order to carry out fitting and assembly operations.

Job Details/Responsibilities

• Operate machinery and equipment associated with the production of goods following documented manufacturing procedures.  
• Performs quality inspections through the assembly process to ensure compliance with regulatory standards and product specifications. Document all sub assembly activities including component tracking and production matrix (authorized electronic record).
• Maintains a clean and organized work area to facilitate efficient workflow and ensure compliance with quality and safety processes / requirements.
• Notifies management of violation or deviations to manufacturing standards, quality, and safety procedures immediately when recognized. 
• Contribute to a positive work environment by fostering open communication, teamwork, and commitment to excellence. 
• Positions, fits, or aligns parts on workbench, floor, or machine, following diagrams (Tapi charts, visual aids, among others), guides, hole patterns, reference marks (color code), or work orders.
• Drills, taps, or reams holes to prepare parts for assembly, using a stationary bench.
• Holds parts during assembly, using hands, clamps, or other work aides.
• Pours, stuffs, or otherwise fills products or containers with specified amount of material.
• Measures and marks reference lines and points on parts according to specifications, using template, rule, or another marking device.
• Cuts materials, such as suture, plastic dimensions, or shapes, using cutting machine, scissors, knife, or blade.
• Reads process charts, work orders, or other specifications to determine assembly sequence, machine and tooling requirements, measurements, and tolerances.
• Inspects, tests, and verifies accuracy of assembled parts for conformance to standards, using measuring or testing equipment, or by visual examination.
• Adjusts, rework, or replaces defective component product parts as requested and in compliance with standard procedures.

Job Responsibilities (continued)

• Cleans dust, dirt, oil, and other foreign matter from material or machine surfaces, using cleaning solution, rag, or air hose.
• Lifts, loads, sorts, and moves materials, supplies, and finished products between storage and work areas, using pushcart.
• Packages product in containers for shipment.
• Notifies management of violation or deviations to manufacturing and safety procedures and guidelines immediately when recognized.
• Ensure compliance with all TPR procedures and all applicable regulatory agency requirements.  
• Other duties as assigned.

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Capacities to calculate (rounding, addition and subtraction), coordinate, detect, evaluate, inspect, and collect. 
• Basic knowledge in computers, preferred. 
• Must have good interpersonal and communication skills. 
• Ability to work in teams and follow detailed work instructions. 
• Ability to read and understand documents both in English and Spanish, preferred. 
• Must Inspect and evaluate the quality of products (color code). Experienced utilizing microscope, preferred.
• Ability to work/manage small components. 
• The ability to quickly make coordinated movements of one hand, a hand together with its arm, or two hands to grasp, manipulate, or assemble objects, is a must.
• Ability to make precise adjustments quickly and repeatedly in moving the controls of a machine or vehicle to exact positions, is a must.
• Ability to make precise adjustments quickly and repeatedly in moving the controls of a machine or vehicle to exact positions, is a must.
• Ability to make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or assemble very small objects, is a must.
• Ability to correctly follow a given rule or set of rules to arrange things or actions in a certain order. The things or actions can include numbers, letters, words, pictures, procedures, sentences, and mathematical or logical operations, is a must.
• Ability to make fast, simple, repeated movements of the fingers, hands, and wrists, is a must.
• Ability to keep the hand and arm steady while making an arm movement or while holding the arm and hand in one position, is a must.
• Ability to coordinate movements of two or more limbs together (for example, two arms, two legs, or one leg and one arm) while sitting, standing, or lying down. It does not involve performing the activities while the body is in motion, is a must.

Qualifications/ Background Experiences

• High School Degree or equivalent (GED), is a must.Previous experience working in a medical device or pharmaceutical industry, preferred.