Material Handler Sterilization (Irvine)

Applied Medical•Irvine, CA

10d•Onsite

About The Position

Join Applied Medical and be at the forefront of revolutionizing medical device manufacturing. As part of our Material Handler team, you will work with cutting-edge sterilization equipment, utilizing Ethylene Oxide (EO) and Electron Beam (E-beam) technologies. As a vital member of our team, your role will involve operating state-of-the-art equipment to execute the essential sterilization processes. The products manufactured by Applied Medical undergo sterilization in-house, and your contribution will directly impact the quality and safety of our medical devices. Ethylene Oxide (EO) sterilization: Ethylene Oxide (EO) is a highly effective sterilization method for medical devices, in this process, devices are placed in a chamber, and exposed to EO gas mixed with Nitrogen (N2) to enhance penetration. The gas disrupts microorganism Deoxyribonucleic Acid (DNA) during exposure. Afterward, the products are transferred to another chamber where aeration takes place this removes residual EO until it is safer for team members to handle the products. Electron Beam (E-beam) sterilization, The electron beam sterilization process begins with an electron beam accelerator. E-BEAM uses high-power state-of-the-art accelerators to create a powerful beam of electrons. The beam scans vertically to create a curtain of electrons, which shower and safely sterilize the Products that they strike. The carrier system moves the products through an area where high-energy electrons are emitted.

Requirements

High school graduate, General Education Development (GED), or work equivalent.
Flexibility to work on 1st, 2nd, or 3rd shift within our Irvine Warehouse Facilities.
Minimum of one year of experience within medical manufacturing or warehouse operations.
Ability to stand and work continuously for several hours at a time.
Capability to occasionally lift objects weighing up to 50lbs.
Knowledge of Systems, Applications, and Products in Data Processing (SAP).
Self-sufficiency in completing tasks with minimal supervision.
Read, write, and speak English.
Understand and comply with safety rules and company policies, per Applied Medical’s handbook.
PPE may include full faced respirator and clean shaven.

Nice To Haves

Ability to problem solve and work in a team.
Capability to cross collaborate in the warehouse.
Ability to maintain detailed records of the sterilization process.
Commitment to quality control.
Knowledge of trouble shooting equipment.

Responsibilities

Incoming materials: At our Irvine location, incoming products undergo a thorough documentation review to ensure compliance with Manufacturing Instructions (MI) requirements. Approved products are then moved to the sterilization building area. You will be using equipment such as pallets jacks, and forklifts.
Sterilization: Loading products into the sterilization chamber and initiating the appropriate cycle. The sterilization cycle is closely monitored to ensure that specified parameters are met. Once sterilization is complete, the products are transferred to an aeration chamber to allow for outgassing, this transfer is handled using an automated conveyor system.
Documentation Review-Release of Products: Team members review documentation per MI requirements. This review ensures adherence to specified standards. Additionally, the team member is responsible for repalletizing products before delivering them to the Quality department for Final Inspection.
Safety Protocols: Fulfill and sustain respiratory protection training and fit testing requirements, undergo 40 hours of HAZWOPER (Hazardous Waste Operations and Emergency Response) training, undergo a thorough medical evaluation, adhere to proper usage protocols for personal protective equipment (PPE), and undertake DOT (Department of Transportation) training as directed by management.
Incoming Materials: The E-beam sterilization involves receiving and preparing products for sterilization. The team conducts a physical inspection and counts all cases, ensuring that the right quantities are received per MI. Multiple systems are utilized to receive and track products.
Sterilization: Operating the sterilization system includes scheduling sterilization recipes on the system, team members undergo thorough radiation safety training, ensuring a comprehensive understanding of protocols and precautions. As a standard practice, individuals are required to wear dosimeters daily, providing continuous monitoring of radiation exposure levels. Additionally, any Personal Protective Equipment (PPE) provided by Applied Medical is diligently worn, to ensure the correct dose was applied to the product, documentation review, and any system issues are troubleshooted, as needed.
Documentation Review-Release of Products: Team members review documentation per MI requirements. This review ensures adherence to specified standards. Additionally, the team member is responsible for delivering products to the Quality department for Final Inspection.
Safety Protocols: Team members undergo thorough radiation safety training, Team members are required to wear dosimeters daily, providing a continuous monitoring of radiation exposure levels. Additionally, any Personal Protective Equipment (PPE) provided by Applied Medical is diligently worn.
Basic Office Software: Knowledge in basic office software such as excel, outlook and word will be used to create reports, document procedures and record keeping.