Vicryl Pack and Seal Operator

Ethicon is currently recruiting for a Vicryl Pack and Seal Operator to be located in our Cornelia, GA sites.

JOB SUMMARY

Responsible for using equipment for the assembly and processing tasks to produce finished products according to established specifications. Accountable for adhering to all quality and safety guidelines.

Safely and efficiently execute daily tasks related to the production of absorbable suture. Typical tasks include packing, sealing in foil pouches and canning of bulk spools.

DUTIES & RESPONSIBILITIES

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Operates production equipment to produce subassemblies or finished products.

Assists with set up of equipment.

Assists with quality control inspections of products on assembly line.

Cleans equipment as needed.

Notifies supervisor of maintenance and/or repairs needed on equipment.

Prepares accurate records/documentation related to work in progress.

Reports production problems.

ESSENTIAL FUNCTIONS

Pack & Seal - Strands

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

Canning - Bulk Spools

1. Check Vacuum / Temperature / Time of Tenney oven to be canned
2. Turn on the canning equipment and ensure that the canner is operating per specification requirements.
3. Verify the quality of the can seal. Perform the vacuum test to ensure the integrity of the can seam.
4. Lube the canner at the required intervals and per specification.
5. Place the spooled suture material in a can, place lid in canner and complete the canning cycle.
6. Package cans into shipping cartons and identify with appropriate labels.
7. Follow Line Clearance Procedure

OTHER RESPONSIBILITIES:

• 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) where applicable.
• Ensure safe working conditions and practices in the department
• Utilize applicable software systems as needed for the job (e.g. Compliance Wi re, ADAPTIV, etc.)
• Consistently meet required work performance targets (RE's), if applicable
• Support LEAN and Six sigma Initiatives.
• Follow written specifications to manufacture product
• Support Maintenance Excellence (ME2) including 6S and Operator Asset Care.
• Consistently meet required Training due date targets.
• 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.
• Support Plant Diversity Process.
• Adhere to FDA quality and worldwide quality systems.
• Maintain certification for testing.
• Use associated test equipment.
• Package and prepare product for shipment.
• Work in a team environment, demonstrating teamwork in identifying, evaluating, and resolving problems within the department.
• 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