Clean Room Production Coordinator - Night Shift

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 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.
• 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.

Education/Experience:

• High School Diploma or equivalent required. Some college desired.
• At least 1 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, enrolled in the Leadership Development Program within 6 months of hire with a successful completion of the program.
• Lean Manufacturing experience is preferred.
• Train-the-Trainer Certification, or equivalent required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• 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.
• Basic knowledge of raw materials, inventory, production processes, barcode scanning and labeling controls, inspection methods, 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 operators, and management 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 assist in bring resolution to departmental matters.
• Ability to efficiently coordinate assigned operators to ensure production schedules are met as well as quality and accuracy of work performed meets GMPs.

Work Environment:

• Requires frequently working in 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 Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off Volunteer PTO
• Employee Assistance Provider (EAP)

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.