Under general direction from Mfg. Manager or Designee perform a variety of activities which include, but not limited to position, insert, assemble, clean, count, pack and/or inspect a number of materials, parts, components and/or product, selecting appropriate procedures and/or methods following Company standards as stated on work instructions and/or operational guidance’s. Manufacturing operations may require manual operation equipment and/or semi-automatic feed or simple operation.
Principal Duties and Responsibilities
- Responsible for performing variety of operations in the designated production work area under a specific instructions and approved procedure using highest quality standards making sure the finished work meets all the products requirements.
- Perform all types of assembly work as required per approved procedures.
- Support and assist to manufacturing personnel (e.g. system technicians, engineers and other support personnel as required) in the timely evaluation and solution of manufacturing problems ensuring compliance with the established Quality System.
- Responsible for compliance with the amount of work required according to area production plan and/or production system established (e.g. Manufacturing Order, Kanban Card, etc.).
- Responsible for complying with the procedure laid down assembly a piece at a time (one-piece-flow or one lot flow) as work cells established.
- Ensure follow all documentation and established processes and understand visual aids procedures.
- Be able to assimilate and perform small repairs or rework operations, work with needles and threads, touch up, parts replacement, repacks, and computer data entries, create and/or receive manufacturing orders, etc. required and/or applicable.
- Capable to work with variety of tools and equipment such as: soldering iron, pneumatic tool, sealers, welders, instrumentation equipment’s, computers, automated machines, etc. as required and applicable.
- Perform mechanical and/or electrical test as per established procedures as applicable.
- Under machine operation process the incumbent shall be capable to perform daily, required maintenance to equipment and/or unscheduled maintenance as per established maintenance procedures as applicable.
- Generate and maintain production related records including qualities records, as required.
- Maintain Supervisor or Designee informed all time for any deviation in process that might affect product performance and their quality. Those imply but not limited to problems with the material, parts, components, products, equipment, machinery or tools that are affecting or may adversely affect the quality and quantity of work.
- Responsible for maintain inventory control management First In First Out (FIFO) and required inventory levels to ensure product availability.
- Ensures the materials in the containers and racks are correct and properly identified as specified in the procedures.
- Responsible for the proper use, handling and documentation of materials, parts, and components for manufacturing and non-manufacturing products.
- Responsible for the proper use and handling of machinery, equipment’s and tools.
- Responsible to request materials to Supervisor or Designee for customer order completion and/or shipping process.
- Responsible for the quality of their work performing work and visual inspections, separation, identification and reporting the materials, parts, or products that do not meet the quality requirements set correctly during manufacturing cycles
- Responsible for properly completing and record information about their daily production, materials, parts, waste product (“scrap“), boards QCDP (Quality, Cost, Delivery, People), as applicable, and others as required.
- Responsible for support and enact continuous improvement initiatives; promotes continuous improvement culture throughout the creativity development, improvement recommendations, kaizen event participation and the sustainment of improvement activities implementation.
- Ensure to maintain a good team work relation and promote Best Manufacturing Practices.
- Responsible for the use and care of Personal Protective Equipment (PPE) and/or safety devices installed in manual, automatic and/or semi-automatic machinery, as indicated by Occupational Safety.
Expected Areas of Competence
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Ensures to meet the established Policies, Procedures and Company Rules, Occupational Safety and Physical Plant, Quality, Environmental, Finance, and others.
- Notify the Supervisor and/or Designee damaged equipment and any situation that may present a risk to occupational safety and/or the proper functioning of the machinery and/or equipment in the area.
- Responsible for keeping common usage and work areas clean and tidy following the procedure of 6S.
- Comply with all established manufacturing control procedures in order to assure that final product will be in compliance with specifications approved in order to guarantee compliance with established production controls as required by 21 CFR 820, Subpart G Sec. 820.70.
- Performs other tasks within the work area, as instructed by the Supervisor or Designee.
- The noise level in the work environment is usually moderate.
- The work requires routine walking, standing, bending, sitting and carrying items weighing up 50 pounds.
- Exposure to alcohol odor environment for sanitization and cleaning activities
EXPECTED AREAS OF COMPETENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed below are representative of the knowledge, skill, and/or ability required but not limited to them:
- Pass a manual dexterity test.
- Able to read and write and Spanish, able to read and comprehension English as second language.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to perform basic math skills including adding, subtracting, multiplying, and dividing integer’s numbers.
- Ability to understand written manufacturing instructions (e.g. OG’s, GMP’s, WI’s).
- Ability to read and interpret drawings and measuring devices used within the unit, such as scales, micrometers, calipers, etc.
- Ability to work in a team environment.
- High manual skills and the ability to follow instructions consistently required.
- Basic computer literacy skills.
- Requires a high school education or equivalent
- Proficient in the use of precision measuring instruments, preferably.
- High School Graduate at an accredited institution. Vocational High School desirable.
- One (1) year of prior industry experience, preferably.
Travel requirement as needed, less than 1%.