Monofilament Processor

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

Company Description:

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

Ethicon offers a broad range of products, platforms, and technologies—including sutures, surgical staplers, clip appliers, trocars, and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer, and obesity. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

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.

The Monofilament Processor produces absorbable suture strands from PDS and Monocryl monofilament fibers including Rack Winding, Bulk Spooling and Cutting.  The Monofilament Processor is also responsible for inspecting sutures for defects and works in accordance with process specifications and procedures

Key Responsibilities:

Under general direction 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:

Job with multiple functions separated for Cross Training / Interim Training Purposes.

Rackwinding:

• 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

Annealing:

• 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.

Scouring:

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

Bulk Spooling:

• 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.

Cutting:

• 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.

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,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