Clean Room Production Coordinator - Night Shift

Requisition ID: 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™. Essential Duties and Responsibilities 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. Education / Experience 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. Knowledge and Skill Requirements / Specialized Courses and/or Training 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 meet GMPs. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Requires frequent work in a clean room and controlled environment utilizing specified cleaning agents. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Arthrex Benefits Medical, Dental and Vision Insurance Company‑Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free On‑site Medical Clinics Free On‑site Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Program (EAP) Equal Employment Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. #J-18808-Ljbffr