Monofilament Processor - Nights (1 of 4)

Ethicon Inc., member of Johnson & Johnson's Family of Companies is currently recruiting for Monofilament Processor, located in Cornelia, Georgia

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

• Operates production equipment to produce subassemblies or finished products.
• Assists with set up of equipment
• Cleans and maintains equipment as needed
• Notifies Supervisor/Lead of Maintenanceand/or repairs needed on equipment
• Prepares accurate records/documentation related to work progress
• Reports production problems
• Demonstrate flexibility and willingness for continued training.
• Performs other duties assigned as needed

• Use rackwinding machine to wind spools of Monocryl and PDS fibers for further processing
• Create and verify tickets and labels
• Open cans as needed. Verify moisture content is within specification.
• Place material into nitrogen/vacuum chambers as needed. Verify chambers are sealed.
• Complete required information on the Device history Record (DHR) and other related forms.
• Follow line clearance procedure

• Load racks into appropriate annealing oven and select appropriate cycle.
• Place chart on required oven and lock into place.
• Make periodic checks of the ovens to ensure running within specification.
• Verify chart for accuracy and that all requirements are met at cycle completion.
• Keep track of cleaning schedule and identify ovens requiring cleaning.
• Complete required information on the Device history Record (DHR) and other related forms.
• Follow line clearance procedure.

• Unload anneal ovens and transport material to scour tank.
• Scour material with appropriate cycle per specification.
• Clean anneal ovens as needed.
• Complete required information on the Device History Record (DHR) and other related forms.
• Follow line clearance procedure.

• Load racks onto bulk spooling equipment.
• Create and verify tickets.
• Thread fiber through required guides and onto spool.
• Utilize HMI to select appropriate material and size.
• Start bulk spooling equipment.
• Verify appropriate defect level at completion of spools. Complete required information on the Device History Record (DHR) and other related forms.
• Follow line clearance procedure.

• Inspect the quality of strands on racks. Identify, remove, and replace defective strands.
• Cut remaining strands from racks.
• Measure strand lengths.
• Wrap strand ends together in predetermined amounts and label for subsequent processing.
• Pull samples.
• Verify labels.
• Complete the Device History Record and other related forms using Good Documentation Practices.

• Use pre-formed foil pouches in accordance with the specification requirements. Verify the quality of pouches by performing the pouch tear down test. Record required data in logbook/form.
• Produce required labels for expiration date.
• Prepare foil pouches for loading with suture product.
• Verify tickets and labels using a bar code scanner. Attach the label to the outside of each foil pouch or onto spools and cans.
• Verify that paper drying oven has run per specification before unloading paper.
• Load product into pre-dried paper folders per specification.
• Place foil pouches containing product or spools of material into a Tenny oven and process per specification requirements.
• Periodically check Tenny oven to verify cycle is running within specification.
• After cycle is complete, heat seal the packages per specification or can spools per specification.
• Verify the quality of the final seal and that the heat sealer is producing and record on appropriate form. Make sealing gasket and sealing bar changes to maintain quality of the seal.
• Record all required data on the Device History Record and other appropriate logs/forms using Good Documentation Practices.
• Follow Line clearance procedure.

• Check vacuum / Temperature / Time in Tenny oven to be canned
• Turn on the canning equipment and ensure that the canner is operating per specification requirements.
• Verify quality of the can seal. Perform vacuum testing to ensure integrity of the can seam.
• Lube the canner at the required intervals and per specification.
• Place the spooled suture material in a can, place lid in canner and complete canning cycle.
• Package cans into shipping cartons and identify with appropriate labels.
• Record all required data on the Device History Record and other appropriate logs/forms using Good Documentation Practices

• Comply with all job specific safety procedures and utilize PPE when necessary.
• Comply with quality system requirements as defined within procedures and instructions.
• Use test equipment (Starett Gauge, Mitutoyo Gauge, Microscope, Instron,etc) where applicable.
• Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.)
• Consistently meet required work performance targets (RE's), if applicable
• Support LEAN and Six Sigma Initiatives.
• Support Maintenance Excellence (ME2) including 6S and Operator Asset Care.
• Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation).
• Perform other work-related duties as assigned by supervisor.
• Consistently meet required Training due date targets.
• Maintain certification for testing.
• Knowledge of hand tools helpful
• Follow written specifications to manufacture products.
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• Work in team environment behaving in a CREDO based respectful manner.
• Cover for other operators during breaks, absences, leaves, vacations, etc.

• High school diploma, G.E.D. or equivalent skills, experience, or training.
• Generally, Requires 0-2 Years Work Experience
• One (1) year of manufacturing experience is preferred.
• Medical Device experience is preferred.
• Excellent communication and interpersonal relation skills.
• Problem solving.
• General inspection skills.
• Ability to use snips and scissors.
• Accurate record keeping.
• Ability to operate production and test equipment.
• Basic math skills: add, subtract, multiply, divide, percentages, averages, tolerances.