Clean Room Production Coordinator - Night Shift

Requisition : 66424 Title: Clean Room Production Coordinator - Night Shift

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing Inc. is actively searching for a Production Coordinator in our Packaging Clean Room supporting the Night Shift (Monday through Thursday, 7:30 pm to 6 am) at the Pendleton, SC location. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• 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.
• Maintain 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, including automated robotic assembly equipment as needed.
• Notify of any maintenance or repair issues of any 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 device.
• Perform AQL inspection in accordance with stated inspection 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.
• Promote a safe work environment, including the use of PPE when required, and communicate issues to management that could lead to process delays or safety concerns.
• Train all employees on device assembly and packaging techniques.

• High School Diploma or equivalent required; some college desired.
• At least one year of manufacturing experience related to manufacturing, assembly and/or packaging, including operation of mechanized equipment.
• Successful completion of the Leadership Development Program (Leadership) required; or enrollment in the Leadership Development Program within six months of hire with successful completion.
• Lean Manufacturing experience is preferred.
• Train‑the‑Trainer Certification, or equivalent, required.

• Proficiency in MS Office.
• Thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Ability to read, understand and follow work instructions and documents.
• Understanding of work instructions, routers, BOMs, and DHRs required.
• Ability to interpret and comprehend blueprints, written specifications, technical documents and protocols.
• Basic knowledge of raw materials, inventory, production processes, barcode scanning and labeling controls, inspection methods, equipment and other techniques for effective manufacturing and distribution of goods.
• Ability to generate appropriate product identification labels for packaging requirements.
• Strong documentation skills according to GDP.
• Knowledge of administrative procedures and 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 and material characteristics.
• Ability to perform machine setup, verify validated parameters, determine/ install and use appropriate tooling.
• Business‑language reading and comprehension, simple math solving and verbal communication skills.
• Communicate proactively and effectively all issues and concerns to operators and management in written and verbal formats.
• Problem‑solving for work orders and DHR documentation and reconciliation.
• Monitor lines for process improvement.
• Investigate and assist in resolving departmental matters.
• Coordinate assigned operators to meet production schedules while ensuring quality and accuracy…