Decontamination and Material Handling Technician - Medical Devices

Essential Duties and Responsibilities

• Responsible for following all good manufacturing Practices and SOPs as defined by ACT procedures and policies to ensure that FDA, ISO and ACT quality standards are met.
• Understand and strictly adhere to all established safety, health, and environmental procedures.
• Decontaminate complaint and returned material using industrial washer, sterilizer and other methods appropriate for the material assuring cycles are performed as per defined work instructions, documenting the results as required by procedure.
• Maintain decontamination log for all complaint material that went through decontamination process to ensure traceability and to meet FDA and ISO regulation.
• Log received material in the Arthrex complaints database and ERP system for product traceability.
• Perform inventory functions in the ERP system as required.
• Responsible for the immediate reporting of safety, quality, or any other operational deficiencies.
• Remove complaint material from loads and perform logistic functions to designated labs for testing.
• Ensure that testing requirements are clearly documented in papers with sample shipment.
• Start computerized sterilization cycles according to vendor specifications to ensure validated sterilization processing.
• Review sterilization records to ensure adequate compliance with internal and external requirements for specific loads.
• Prepare devices for review as part of sterilization and/or cleaning validation.
• Work closely with Quality department to ensure we are FDA and ISO compliant.
• Investigate non-conforming inventory to ensure correct material processing.
• Quarantine discrepancy with complaint material and perform logistic function to send back to end customer if applicable.
• Collaborate with Supervisor to ensure PPE, maintaining all the decontamination chemicals, and material needed to successfully perform job is available for use.
• Coordinate for the disposal of biohazardous material and expired chemicals.

Education and Experience

High School Diploma or GED required. Experience with medical device handling and processing preferred.

Knowledge and Skill Requirements

• Knowledge of decontamination processes preferred.
• Ability to work at a desk, in an office area, or in a light manufacturing area including clean room.
• Ability to write and record data and information as required by procedures.
• Basic computer knowledge including Microsoft products Excel and Word.
• Ability to learn and use industrial washers, autoclave, and hand tools.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to comprehend and apply mathematical principles to the degree required to perform the job.
• Ability to verbally communicate ideas and issues effectively to other team members and management.