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

Title:

Senior Production Coordinator (Packaging) – 3rd Shift – Ave Maria, FL.
Division:
Arthrex Manufacturing Inc (US02).

Location:

Ave Maria, FL.

Shift: Sunday–Thursday, 10:00 pm–6:30 am.
Requisition .

• Perform daily, monthly and semi-annual terminal cleaning activities in the clean room.
• Responsible for accessing and following 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.
• Responsible for 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, automated robotic assembly equipment as needed.
• Alert of any maintenance or repair issues of any equipment or tools.
• Perform changeovers and line setups.
• Perform area clearance and maintain line separation while running work orders.
• Responsible for managing and segregating scrap.
• Ensure correct and complete assembly of device.
• Performs AQL inspection in accordance with stated inspection criteria.
• Manages activities involving QC Hold and/or MRB related issues.
• Assist in product and packaging validation tests when necessary.
• Adhere to all Quality System Requirements.
• 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.
• Train all employees on device assembly and packaging techniques.

• High School Diploma or equivalent required. Some college desired.
• 2 year of manufacturing experience related to technical and mechanical aspect of manufacturing including operation of packaging equipment and 1 year experience in a previous position of leadership required.
• Successful completion of the Competency Training within 3 months of hire.
• Lean Manufacturing experience is preferred.

• Proficiency on MS Office required.
• A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Perform tasks by reading, understanding and following work instructions/documents provided.
• Understanding of Work Instructions, Routers, BOM’s, and DHR’s required.
• Ability to interpret/comprehend blueprints, written specifications, technical documents and protocols, rework addendums, data forms, and packaging and work instructions.
• Advanced knowledge of raw materials, inventory traceability and investigation, production processes, barcode scanning and labeling controls, inspection methods and equipment, and other techniques for the effective manufacturing and distribution of goods.
• Ability to generate appropriate product identification labels for Packaging requirements.
• Possess thorough and accurate documentation skills according to GDP.
• Knowledge of administrative procedures and computer systems such as word processing, Documentum, SAP, Agile PLM and Microsoft Outlook.
• Perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics.
• Ability to perform machine setup, verifies validated parameters, determination/ installation and use of appropriate tooling.
• Requires business language reading and comprehension, solving simple math equations and the ability to perform tasks through verbal communication.
• Ability to communicate both proactively and effectively all issues and concerns to management, other coordinators and operators in written and verbal formats.
• Work Order problem solving and DHR documentation and reconciliation.
• Ability to monitor lines for process improvement.
• Ability to assess, investigate, and bring resolution to departmental matters.
• Ability to efficiently coordinate all resources to ensure production schedules are met as well as quality and accuracy of work performed meets GMPs.
• Assists other Coordinators ensuring proper utilization of manpower for continuous flow on the production line.
• Provides back up…