Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Monofilament Preformer- Multiple Shifts (1 of 5), located in Cornelia, GA.
Ethicon, Inc. is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
Duties include safely and efficiently executing daily tasks related to the production of absorbable Stratafix suture in an FDA regulated environment. Typical tasks include preform, rackwinding, annealing, scouring, bulkspooling, and inspection. The Monofilament Preformer will also administer the deployment and utilization of resources for tactical day to day work to achieve a reliable, efficient and productive operation. Utilizes a thorough familiarity with the requirements of US regulations for the manufacture of medical devices, the ISO standard (ISO 13485), and the EC Medical Device Directive, provide compliance education for the facility in support of overall educational strategies.
Monofilament Preformer responsibilities will include:
• Operate the preformer process.
• Perform testing per specification requirements.
• Prepare, record, close out, review, and maintain Device History Records.
• Constantly monitor preform lines & perform corrective action.
• Maintain and troubleshoot equipment.
• Disconnect and connect wiring on dies as needed.
• Align dies during installation and change over.
• Perform all testing and recordkeeping.
• Set up and teardown performer/equipment.
• Load rackwinding machine and wind material onto racks.
• Create and verify tickets and labels.
• Load racks into appropriate anneal oven and change programs if necessary.
• Open cans as needed. Verify moisture content is within specification.
• When placing material in vacuum chambers, verify that vacuum chamber is sealed after closing.
• Place chart on required oven and lock chart into place. Make periodic checks of the oven to ensure they are running within specification.
• After cycle is complete, verify chart status for accuracy and completeness.
• Keep track of anneal oven cleaning schedules for every anneal oven. Flag ovens that need cleaning with appropriate form.
• Complete required data on the Device History Record and other related forms.
• Follow Line Clearance Procedure.
• Load rackwinding machine and unwind racks on to spools.
• Load spools into vacuum chamber.
• Unload anneal ovens and transport cart of material to scouring.
• 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.
• Take completed spools out of the vacuum chamber.
• Can and box completed spools as per specification.
• Complete required information on the Device History Record (DHR) and other related forms.
• Follow the Line Clearance Procedure.
• Work in team environment behaving in a CREDO based respectful manner.
• Comply with all federally regulated programs.
• Adhere to J&J environmental and safety policies and guidelines.
• 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.
• Demonstrates initiative in identifying, evaluating, and resolving problems with the department.
• Possess ability to work independently toward published targets.
• Basic understanding of statistical process control.
• Use hand tools where applicable.
• Maintain certification for testing.
• Follow written specifications to manufacture products.
• Package and prepare product for shipment.
The Cornelia Plant is a 24/7 operation; weekends and holidays are included in the work schedule.Qualifications
• High school diploma, G.E.D. or equivalent skills, experience, and training required.
• Basic computer skills, including ability to navigate effectively.
• Demonstrated ability to set-up, operate, and perform basic maintenance of manufacturing equipment.
• Basic math skills: add, subtract, multiply, divide, averaging, percentages, rounding, tolerances
• Ability to use measuring devices such as micrometers, scales and balances, calculators, tachometers, computer, and Instron test units.
• Ability to use basic hand tools.
• Ability to work independently without continuous supervision.
• General inspection skills.
• Aptitude for electric skills.
• Ability to maintain accurate records.
• Capable of innovative thinking to resolve problems and recommend corrective actions.
• High level of attention to detail.
• Manual dexterity and ability to work with small and intricate parts with precision.
• May require ability to lift up to 30 lbs. on occasion.
• Strong background in math or science, SPC skills, and/or post high school is preferred.
• Knowledge of extrusion, molding, or PDS preprocessing operations is preferred.
• Ability to stand, sit, or walk for extended periods of time.
• Must be able to work either 6:45pm – 7:15am, 6:45am – 7:15pm on a rotating schedule.
• The ability to work occasional overtime and some holidays is required. Primary Location
Ethicon Inc. (6045)Job Function
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