Sterilization Operations Technician 1 - Sc

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for Level I Sterilization Operations Technicians for our Pendleton, SC facility.  The individual in this position will be responsible for the safe, efficient and timely sterilization processing and handling of medical products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Under the direction of the Operations Manager and Supervisor – Sterilization Operations, the operations tech will be responsible for the safe, efficient and timely X-Ray and E-Beam sterilization processing and handling of medical products according to AMI SOPs, specifications and established policies with minimal direct supervision.

Essential Duties and Responsibilities:

• Responsible for following all Good manufacturing Practices and SOP’s as defined by AMI procedures and policies to ensure that FDA, ISO and AMI quality standards are met.
• Understand and strictly adhere to all established safety, health and environmental procedures.
• Maintain AMI shipping and receiving areas to ensure efficient processing of loads.
• Receive, log, examine for damage on all incoming product and place/verify presence of sterility testsamples as required. Ensure that all products are clearly identified per the appropriate work instructions.
• Load product on the conveyor as required by process cycle specifications (PCS).
• Start computerized sterilization cycles according to AMIX specifications to ensure validated sterilization processing. Review sterilization records to ensure adequate compliance to the requirements for each specific load.
• Place and retrieve dosimeters, place and retrieve samples if applicable, repalletize the product, placard the status and wrap the pallet.
• Responsible for the immediate reporting of safety, quality, or any other operational deficiencies.
• Remove samples from loads and deliver to designated labs for testing. Ensure that testing requirements are clearly documented in papers with sample shipment. Set up shipping AMI requirements via standard carriers.  
• Document processing conditions and verify that they meet AMI processing specification requirements. Maintain proper product labeling and segregation through all stages of the sterilization process.
• Responsible for safe sterilizer operation, safe forklift operation, safe irradiation facility practices, and proper use of all personal protective equipment.
• Responsible for monitoring the facility radiation levels and equipment operating alarm conditions to ensure safe and proper operation of facility and equipment.
• Participate in communication meetings, process improvement projects, lean/sigma projects to establish best demonstrated practices for continuous improvement efforts throughout the operation.
• Work in and around the Rhodotron accelerator and dosimetry system.

Education and Experience:

• High School diploma or equivalent required; Bachelor’s degree in Science related discipline preferred
• 2 years manufacturing experience required
• Experience in sterilization preferred
• Experience in a Good Manufacturing Process regulated industry a plus

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

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. Computer skills including Microsoft products and data entry, data acquisition and process operation software. Knowledge of and ability to implement FDA QSR requirements. Experience with process safety including hazard communication, electrical safety and chemical handling safety procedures.

Sterilization Operation Techs will be required to participate in a radiation safety course and pass a written exam.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

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. 
• While performing this job the employee is regularly required to talk or hear.  The employee is frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms.  The position may require prolonged walking and standing, awkward postures, working at heights and in hot or cold conditions.  The employee must be able to lift and/or move up to 30 pounds. 
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Safety Requirement:

The Rhodotron accelerator magnets produce powerful magnetic fields that can adversely affect the operation of pace-makers creating a death hazard to people whose health or life depends on this device. In addition, the dosimeter reader contains magnets that could also adversely affect the operation of a pace-maker. Individuals who have a pace-maker or any similar medical device cannot safely work in this environment.  Questions should be directed to Human Resources, Environmental Health and Safety, and your supervisor.

Employees in this role may be exposed to small amounts of radiation, However, this is very unlikely due to the engineering controls put in place to prevent inadvertent exposure.

Should an employee in this role receive a pace-maker or like device, or should the medical condition of an employee change during employment, for example should an employee become pregnant, then the employee must inform Human Resources and/or their supervisor to discuss if any accommodation(s) may be necessary. 

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. 

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.  The noise level in the work environment is usually moderate.

Drug Free Workplace Screening: Employees in safety sensitive positions will be subject to drug screening prior to and during employment at Arthrex. The company’s drug testing procedure is part of the Arthrex Employee Reference Guide. (ERG)

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.