Sr. Sterilization Engineer 1
Arthrex
- Pendleton, SC
- Permanent
- Full-time
Title: Sr. Sterilization Engineer 1
Division: Arthrex, Inc. (US01)
Location: Pendleton, SCArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Sterilization Engineer I. This is an exciting opportunity to make your mark on a growing organization. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.Main Objective:Maintain Arthrex Manufacturing sterilization processes in accordance with Quality Systems Requirements.Essential Duties and Responsibilities:
- Become proficient in the use and diagnostics of Arthrex's ethylene oxide and/or radiation sterilization equipment.
- Manage and maintain Arthrex Manufacturing ethylene oxide sterilization cycles and/or radiation sterilization processes in compliance with appropriate regulatory standards.
- Perform sterilization cycle evaluations and validations in conjunction with the Sterilization Science and Biological Safety Team
- Supports or performs equipment qualifications and computer system validation, where required.
- Perform audits of Arthrex Manufacturing suppliers, contract laboratories, and critical process suppliers when necessary.
- Act as front room and/or back-room representative during audits by internal teams and notified bodies.
- Ensure proper maintenance of Arthrex Manufacturing files demonstrating vendor compliance and performance including authoring and/or reviewing sterilization validations and product adoptions into existing cycles in conjunction with the SSBS Team.
- Recognize and address sterilization processing issues
- Evaluate, author and optimize sterilization procedures including employee training.
- Implement and manage the “certified operator” training program or support existing programs.
- Provide EH&S with timely communication on safety training and environmental compliance.
- Track and trend sterilization non-conformances and processing metrics
- Facilitate resolution of sterilization related MRBs CAPAs, non-conformances, and audit findings.
- Provide assistance in assessing device design for ethylene oxide sterilization and radiational sterilization methods when necessary.
- Encourage a continuous process improvements environment
- Support Arthrex business and expansion goals
- BS Degree in biology/microbiology, chemistry, or related science field required
- 5 years of relevant experience required.
- Experience with Ethylene Oxide exposure and/or E-beam, X-ray or Gamma radiation modalities preferred
- Certified Industrial Sterilization Specialist (CISS-R, CISS-EO) preferred.
- Specialized training manufacturing operations, system design and development, industrial statistics, and technical writing preferred. Experience in working with sterilization standards (specifically, ISO 11135 and ISO 11137)
- Provides feedback and recommendations to management on initiative performance, goals and status.
- Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
- Knowledgeable of FDA and ISO guidelines for the sterilization validation of medical devices required.
- Manufacturing process knowledge preferred.
- Project management and communication skills training preferred.
- Working knowledge of terminal sterilization methods preferred.
- Hands on experience performing laboratory testing activities preferred.
- Test protocol and report writing experience preferred.
- Working knowledge of device clinical use and associated harms and hazards
- Knowledge of orthopedic surgery principles, theories, and products preferred.
- 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)