Sterility Assurance Tech

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing, Pendleton, SC. Location is actively searching for a Sterility Assurance Technician, to provide assistance in preparing non-sterile materials for transport to third party sterilization facilities in accordance with Quality Systems Requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This is a first shift, 6am-4:30pm, Monday through Friday position.

Essential Duties and Responsibilities:
Create sterile load folder and sterile load number

Provide the Arthrex load number to the contract sterilizer

Identify the proper cycle to be run at the contract sterilizer

Label outgoing pallets

Pre-shipment review per applicable work instructions

Provide contract sterilizers with the appropriate process challenge devices for use in monitoring the efficacy of the sterilization processes used by AMI.

Provide contract sterilizers with BI placement maps and laboratory work requests

Assist in maintaining the AMI sterile product release process.

Perform activities related to the shipping of non-sterile product to sterilization and the receiving of sterile product from sterilization.

Assist in collecting, maintaining, and interpreting pertinent regulatory information such as sterile load files and sterility test data.

Education and Experience:
High school diploma or equivalent required

2 years’ experience in one of the following fields: Microbiology, Health care, pharmaceutical, or medical device industry is required

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

Ability to work at a desk, in an office area, or in a light manufacturing area including clean room. Computer skills including Microsoft products. Knowledge of and ability to implement FDA QSR requirements.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Vision Requirements:
Visual acuity necessary to do the job safely and effectively.

Specific vision abilities required by this job include close vision.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Nearest Major Market: Greenville

Nearest Secondary Market: South Carolina