Senior Machine Operator; Packaging- 3rd Shift- Ave Maria, FL

Senior Machine Operator (Packaging)- 3rd Shift
- Ave Maria, FL.

Title: Senior Machine Operator (Packaging)- 3rd Shift
- Ave Maria, FL.

Division: Arthrex Manufacturing Inc (US02)

Location: Ave Maria, FL.

Arthrex Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is actively searching for a Senior Machine Operator to produce Quality Medical Instruments in accordance with Arthrex Manufacturing Inc. procedures and packaging processes in a safe and effective manner to meet and exceed the customer’s needs. Ensures that production plan goals are accomplished by supporting production personnel in the assembly, inspection, and packaging of products.

Adopt an environment of continuous improvement to develop more robust procedures and improvements within existing processes to produce cost effective quality products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Third Shift - Sunday
- Thursday, 10:00PM- 6:30AM

Essential Duties and Responsibilities:

• Perform daily, monthly and semi-annual terminal cleaning activities in the clean room.
• Perform manual and fixture assisted device assembly and packaging on medical device components, kits, convenience packs and/or any clean room specific device assembly as assigned.
• Print and apply labels onto pouches and blisters. Assist in label reconciliation as needed.
• Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection.
• Operate clean room specific equipment, automated robotic assembly equipment as needed.
• Alert of any maintenance or repair issues of any equipment or tools.
• Assist during changeovers and line setups.
• Responsible for accessing and following packaging instructions and work instructions from PLM and Document management systems based on product structure requirements.
• Inspect unit assembled and sealed for potential defects.
• Responsible for managing and segregating scrap.
• Ensure correct and complete assembly of device.
• Responsible for DHR and ERP accuracy and completion.
• Supports activities involving QC Hold and/or MRB related issues.
• Promotes a safe work environment including the use of PPE when required. Communicates issues to management that could result in process delays and/or safety issues.
• Adhere to all Quality System Requirements.

Education/

Experience:

• High School Diploma or equivalent required.
• At least 1 year of manufacturing experience required related to assembly and/or packaging of products using manual and mechanized assembly processes.

Skills:

• Experience with Microsoft Office products desired.
• A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Must have the ability to perform tasks by reading, understanding and following work instructions/documents provided.
• Knowledge of and ability to interpret/comprehend written specifications, and packaging and assembly work instructions.
• Knowledge of raw materials, production processes, quality control and other techniques for manufacturing of products.
• Basic understanding of BOMs and Routers and their use for manufacturing.
• Demonstrated understanding of GMPs and DHR content.
• Possess thorough and accurate documentation skills according to GDP for setup and operation of the sealers.
• Understanding of inventory traceability, production processes, inspections, label reconciliation processes, and other techniques for effective manufacturing, distribution, and traceability of products.
• Ability to perform machine setup, verifies validated parameters, determination/ installation and use of appropriate tooling.
• Ability to perform testing.

Knowledge:

Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.

Reasoning Ability:

Develops solutions to a variety of problems of moderate scope and complexity. Refers to work instructions, policies and practices for guidance.

Work is closely supervised. Follows specific, detailed instructions.

Reasoning Ability:

Ability to define problems, collects data, establish facts,…