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Sterilization Sciences Specialist II

Company: Arthrex, Inc.
Location: Naples
Posted on: May 3, 2021

Job Description:

Requisition ID: 48511 Title: Sterilization Sciences Specialist II Division: Arthrex, Inc. (US01) Location: Naples, FL

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sterilization Sciences Specialist II to help us Maintain Arthrex, Inc.'s sterilization and end-user reprocessing projects, validations, and monitoring program in accordance with Quality Systems Requirements. Excellent communications and analytical skills, strong technical project management skills and a Bachelors' degree in Engineering, biology/microbiology, chemistry, or related science field will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties and Responsibilities:

* Participate in design review meetings and as a key member of product design teams to assess and validate devices for proper sterilization methods, e.g., radiation, ethylene oxide, and end-user reprocessing etc.; * Direct and maintain global corporate programs for sterilization cycle maintenance and end-user cleaning and sterilization instructions; * Ensure Arthrex's corporate sterilization programs are maintained in accordance with all relevant international standards, e.g., ISO 11135, ISO 11137, ISO 17665, etc. as well as domestic and foreign regulatory requirements; * Coordinate all activities related to validations and/or testing, and directly interact with external and corporate laboratories, and sterilizers personnel to accomplish the assigned tasks; * Perform documented assessments, and validations as required of product and process changes for impact to sterilization process efficacy; * Act as lead auditor and/or subject matter expert for quality management system audits of Arthrex's global supplier base including critical contract manufacturers, sterilization service providers, and laboratories in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives; * Support manufacturing organizations in defining requirements for and ensuring infrastructure systems are efficacious in controlling and preventing potential contamination from device contacting materials, utilities, environments, etc.; * Ensure proper maintenance of files demonstrating internal and vendor compliance and performance including authoring and/or reviewing sterilization validations and product assessments into existing cycles, routine product and environment monitoring reports, non-conformances, CAPA's, etc.; * Mentor teams, share experience, and provide best practices to sterilization / quality staff related to sterilization systems, corporate policy, and regulatory requirement; * Encourage and foster an environment based upon a foundation of continuous process improvement and industry benchmarking; * Support and lead Arthrex's business and expansion goals; * Must be able to travel up to 10% of the time.

Education/ Experience: 3 Years with BS Degree in Engineering, biology/microbiology, chemistry, or related science field


* Knowledgeable of FDA and ISO guidelines for the sterilization assessment of medical devices required. * Manufacturing process knowledge preferred. * Project management and communication skills training preferred. * Working knowledge of terminal sterilization methods. * Hands on experience managing laboratory testing activities. * Test protocol and report writing experience preferred.

Knowledge: Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.

Reasoning Ability: Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.

Discretion/ Latitude: Works under very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

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.

Keywords: Arthrex, Inc., Cape Coral , Sterilization Sciences Specialist II, Other , Naples, Florida

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