Description GENERAL FUNCTION Operator will be responsible and perform as follows: · Maintain equipment operation, monitoring, and performance of grinding system (grinders and processors). · Know processes and QC specifications. · Perform cannula loading/unloading of grinders and/or clip processors as required. · Inspect and remove defective product. · Maintain product quality, equipment performance, and production performance. · Make process equipment adjustments, repairs, and service as required so that continuous work patterns and operations are maintained. · Notify set-up, utility, and technicians when necessary. · Clean up as required. · Maintain accurate production waste, quality, labor, etc., records. JOB ELEMENTS 1) Start A. Supplies – Check and obtain adequate supplies to maintain auto grinding of cannula (cannula, cartridges, clips, lid/base rubbers, etc.) B. Equipment 1) Check all equipment for proper set-up and adjust and/or replace as needed (grind fixtures, speeds, coolant, sensor position, bead blaster, lid/base rubbers, etc.) 2) Continually monitor operation’s quality and process equipment. 3) Make adjustments for cam heel effect using bead blaster for quality cannula. C. Load/Unload 1) Add/transfer product to grinder/clip processor as needed. 2) Add/fill clips/cartridges as needed. 3) Remove finish pointed cannula from grinder as required. 4) Inspect each pointed cannula clip or cartridge. 5) Fill cannula hopper with cannula. 6) Unload/load cartridge/clip from grinder/processor as needed. D. Assists – Notifies set-up and/or technician when needed for major adjustments and repairs. 2) Operation A) Transfer 1) Use tray to transfer clipped cannula between workstations. 2) Load/unload and inspect cannula at work stations as needed to keep grinding system operating effectively and efficiently, maintaining quality, performance, and waste. 3) Maintain workflow pattern of sequencing so that equipment operates a maximum amount of time. B) Q.C. 1) Inspect pointed cannula for defective cannula per applicable QC Specifications. 2) Remove defective cannula during inspection to the appropriate waste container. 3) At first QC check, make checks per QC Specifications (rotation, bevels, overall length, point length, bore, burns, etc.) 4) Perform periodic and as needed QC checks per QC Specifications (dimensional checks, point length, bevel length, overall length, also burr clogs, rotation, etc.). 5) Use macroscope, microscope, calipers, laser rotation, or other test equipment to perform QC requirements. C) Service 1) Add proper cut cannula to grinder/processor as required. 2) Re-orientate cannula in grinder/processor hopper as needed for feeding and preventing jams. 3) Keep enough cannula loaded on grinders/processors to maintain continuous grinding. This is to achieve proper machine sequencing of grinders, cannula inspection, and processor. 4) Remove filled cartridge from grinders/clip processors and replace with empty cartridge, re-position full cartridge sensor and restart processor. 5) Inspect empty cartridge/clip for damage and set aside for repair (screen holes, screws missing, cracked cartridges, bent, etc.). 6) Prepare filled cartridge for next operation and set aside for pickup (installing end cap, tighten cartridge, use proper color pen per item to mark ID tags with “CA” number, gauge, length, etc.) 7) Clean/clear any jams in all equipment making practice and use of OSHA/Plant required Lock Out procedures and use of required gripper tools. 8) Monitor grinding/clip processor for damaged product and remove defective product (hooks, blunts, etc.) 9) Clean up daily/weekly equipment, machines, QC area, and other work areas as scheduled and/or necessary. D) Adjustments 1) Make minor machine adjustments and set-ups to maintain continuous product quality and process performance (lid/base rubber changes, wheel sensor, overall length, point rotation, blast nozzle, lid pressure, water flow, burrs, burnt point, etc.) 2) Inspect clip processor for belt wear periodically. (At about every two-hour interval, check belts on processor fraying which cause foreign material on cannula). 3) Notify set-up/technician when major adjustments or repairs to mechanical or electrical systems are necessary. E) Records 1) Record results of QC tests on proper charts and record forms per QC specification requirements (rotation angle, burrs, clogs, hooks in cartridge and other checks as required or become necessary). 2) Maintain accurate labor, production, waste, and quality records. 3) Turn in records/charts as required. F) Other 1) Operate different grinding banks for different cannula product items. 2) Operate two grinding banks through breaks effectively. 3) Operator to make product changeovers (run product out of machines, clear/clean out product in machines, add/start new product). RESPONSIBILITIES 1. Reports directly to product line coordinator and to shift coordinator and has no authority over others. Able to work effectively in a team, accurately, and with limited supervision. 2. Executes additional duties as required by coordinators. 3. Must be familiar with all specifications as outlined in the Manufacturing Set-up Procedures, 4. Understand Process Specifications, Preventative Maintenance and Quality System Manual, blueprints, and GMP manuals, which pertain to this operation. 5. Be available to report to work during off shift hours to aid in machine repair or set-up as required. 6. Must comply with department protective clothing, safety and management policies. 7. Must be familiar with specifications and documentation associated with operations of this position. The operations of this position may specify use of chemicals. In such cases, completion of periodic Resource Conservation and Recovery Act and Right-To-Know training will be required for these chemicals.
Qualifications Required Knowledge, Skills, Experience, and Abilities Level of Education/Knowledge needed: Minimum Requirements · High School diploma or GED Desired Education/Knowledge · Knowledgeable of ISO & FDA regulations and BD Quality policies Level of Experience needed: Minimum Requirements · No previous experience required. · Previous manufacturing experience desired. Level of Skills Needed: Minimum Requirements: · Proficient at reading and writing English Ability to: · Work with others (interpersonal skills) · Give and receive feedback · Train others · Solve problems and make informed decisions · Plan and organize job tasks · Set priorities and timelines · Communicate (both verbally and in writing) · Break down tasks into their parts · Take initiative (see what needs to be done and then do it) Desired Skills: Proficiency using: · MES · Precision measuring instruments · BD inspection methods and documentation Accountability: BD has the following Core Values that are expected behavior from every associate:
We Treat Each Other With Respect
We Do What Is Right
We Always Seek To Improve We Accept Personal Responsibility
Becton Dickinson - 21 months ago