Senior Production Coordinator; Packaging- 3rd Shift - Ave Maria, FL

Overview

Senior Production Coordinator (Packaging) – 3rd Shift – Ave Maria, FL. Arthrex Inc. is a global medical device company focused on new product development and medical education in orthopedics. The successful candidate will assist in producing quality medical instruments in accordance with Arthrex Manufacturing Inc. procedures and packaging processes, safely and efficiently, to meet customer needs. This role supports production operations in assembly, inspection, and packaging to meet plan goals and fosters continuous improvement of procedures and processes.

Shift:
Third shift, Monday – Friday, 9:00 pm – 5:30 am.

• Perform daily, monthly and semi-annual terminal cleaning activities in the clean room.
• Access and follow packaging instructions and work instructions from PLM and Document Management systems based on product structure requirements.
• 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.
• Ensure DHR and ERP accuracy and completion.
• Apply labels onto pouches and blisters including label reconciliation.
• Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection.
• Operate clean room specific equipment and automated robotic assembly equipment as needed.
• Report maintenance or repair issues for equipment or tools.
• Perform changeovers and line setups.
• Maintain area clearance and line separation while running work orders.
• Manage and segregate scrap.
• Ensure correct and complete assembly of devices.
• Perform AQL inspection in accordance with stated criteria.
• Manage activities involving QC Hold and/or MRB related issues.
• Assist in product and packaging validation tests when necessary.
• Adhere to all Quality System Requirements and promote a safe work environment, including PPE where required.
• Communicate issues to management that could result in process delays and/or safety issues.
• Train all employees on device assembly and packaging techniques.

• High School Diploma or equivalent required; some college preferred.
• 2 years of manufacturing experience related to technical and mechanical aspects of manufacturing including operation of packaging equipment; 1 year leadership experience required.
• Successful completion of Competency Training within 3 months of hire.
• Lean Manufacturing experience is preferred.

• Proficiency in MS Office.
• Thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Ability to read and follow work instructions/documents; understanding of Work Instructions, Routers, BOMs, and DHRs.
• Ability to interpret blueprints, specifications, protocols, data forms, and packaging/work instructions.
• Advanced knowledge of raw materials, inventory traceability and investigation, production processes, barcode scanning and labeling controls, inspection methods and equipment.
• Ability to generate appropriate product identification labels for packaging requirements.
• Accurate documentation skills according to GDP.
• Knowledge of administrative procedures and computer systems (Word, SAP, Agile PLM, Documentum, Microsoft Outlook).
• Ability to perform tests and evaluations on materials, products, and processes to measure performance or characteristics.
• Machine setup, parameter verification, and appropriate tooling utilization.
• Strong communication skills, proactive issue reporting, and coordination with management, coordinators and operators.
• Work order problem solving and DHR documentation/reconciliation.
• Ability to monitor lines for process improvement and resolve departmental matters.
• Efficient coordination of resources to meet production schedules with GMP compliance.
• Mentor and back-up supervision for Packaging Clean Room when supervision is not present.
• Ability to train operators and other trainers on competency tasks.

• Regularly contributes to development of new concepts, techniques and standards; considered expert in the field within the organization.
• Develops solutions to complex problems using ingenuity and…