Operations Specialist- 3rd Shift Packaging- Ave Maria, FL

Requisition : 64256 Title: Operations Specialist- 3rd Shift - (Packaging)- 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 an Operations Specialist to work at our Ave Maria, FL. Location on the Third Shift. The successful candidate will 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™.

• Performs and documents inspections on parts using engineering prints, inspection procedures or work instructions
• 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.
• Records data, applying statistical quality control procedures
• May perform, as needed, nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics
• Print and apply labels onto pouches and blisters. Assist in label reconciliation as needed.
• Operates pouch and blister sealing equipment and performs inspections per established work instructions
• Verifies validated parameters and use of appropriate tooling
• Load and orient unit devices into unit packages and/or automated equipment
• Inspect unit assembled and sealed for potential defects.
• Assists Production Coordinator/Sr. Production Coordinator with setting up lines
• Performs daily cleaning, monthly terminal cleaning and semi-annual terminal cleaning activities in the clean room
• Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection.
• 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.
• 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.

• High School Diploma or equivalent required
• 1 year of manufacturing, or, a combination of 1 year of manufacturing and quality control experience required
• Successful completion of the Competency Training within 3 months of hire.

• Proficiency with Microsoft Office products is desired.
• A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Ability to correctly perform tasks by reading, understanding and following work instructions provided.
• Knowledge and ability to interpret/comprehend blueprints, written specifications, technical documents and protocols, rework addendums, data forms, and packaging and work instructions.
• Possess thorough and accurate documentation skills according to GDP.
• Perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics.
• Ability to assess, investigate, and assist in resolving departmental matters.
• Ability to communicate both proactively and effectively all issues and concerns to the team and management in…