Manufacturing ​/ Production Operator, Quality Engineering

SUMMARY

This position is responsible for performing and maintaining certification of 0-5 functions of cleaning, inspecting, identifying, function testing, packaging and sealing medical devices.

• Chemically clean and reprocess medical devices
• Functional Testing with electronic test fixtures
• Inspecting medical device visually, through video magnification and microscope
• Intricate usage of micro-tools and experience using a ruler for measurements
• Operate multi-sonic tanks and other cleaning machinery
• Must be able to tolerate the smell of silicone
• Package and label medical devices while maintaining job integrity
• Accurately identify medical devices by part number, and print and apply barcodes
• Operating a Heat-Sealing Band Sealer
• Final inspection of devices provided by Inspection area prior to sealing
• Follow documented and defined Work Instructions
• Functionally test sealer daily to ensure standards are met and complete appropriate logs
• Keep individual jobs intact throughout entire process and perform jobs in “first in-first out” basis
• Verify job number on traveler ticket with job number in Critical Manufacturing
• Keep in compliance of safety measures including the use of all PPE. Frequent exposure to pre-wash and enzymatic detergent.
• Navigate Critical Manufacturing as needed to complete each job
• Locate Work Instructions (Protocols) in the computer.
• Meet or exceed all quality and productivity expectations
• Ability to work, as needed, in other areas of production
• Able to work overtime as needed
• Know and follow policies and procedures related to work activities performed in area of responsibility
• Complete training in area of responsibility. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re‑training in areas such as environmental health & safety
• Assist with training and qualifying other team members to perform a variety of processes and operations
• Committed to building a positive culture
• Other responsibilities may be assigned & not all responsibilities listed may be assigned

The minimum education and experience required to perform this job competently.

• 0 to 1 years’ experience in relevant Jabil production position OR equivalent external work experience
• Prior experience in the medical device industry is preferred
• Familiar with and able to navigate MES or New Critical Manufacturing System preferred
• Basic knowledge of FDA and ISO regulations preferred
• Willingness to learn and take on additional responsibilities
• Must have excellent hand and eye coordination/dexterity
• Ability to learn quickly and to identify, logically analyze, and solve work related problems
• Ability to learn overall understanding of process flow and resources within the organization
• Ability to maintain high work standards and concern for the quality of work; to work reliably and responsibly to improve daily
• Ability to read, write, count, and understand English.
• Ability to function independently as well as part of a team
• Ability to manage multiple priorities in fast‑paced environment

• Lift/carry up to 10 lbs frequently and up to 50 lbs occasionally
• Push/pull, up to 100 lbs occasionally
• Bend up to 30 degrees, kneel/squat, sit, overhead reach occasionally
• Twist/turn, stand/walk and rotate activities/positions frequently
• Grasping – light and out‑stretched arms both hands
• Torquing/crimping, grasping-light, and out‑stretched arms with both hands

Ability to operate a personal computer. Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Read and understand visual aid.

Must be able to calculate quantity of parts to be prepped and ready for use at any time. Ability to add and subtract two‑digit numbers and to multiply and divide with 10's and 100's.

Ability to apply common sense understanding to carry out simple one- or two-step instructions. Ability to deal with standardized situations with only occasional or no variables.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. An individual’s primary workstation is located on the manufacturing floor. The noise level in the work environment is moderate.