Sr Sterilization Sciences Specialist at Arthrex, Inc. in Naples, Florida

Job Description:

Main Objective:

Maintain Arthrex, Inc.’s sterilization and end-user reprocessing projects, validations, and monitoring program in accordance with Quality Systems Requirements.

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.

Skills:

• 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.


• Working knowledge of device clinical use and associated harms and hazards

• Knowledge of orthopedic surgery principles, theories, and products preferred.


• Personnel supervision experience preferred

Education/ Experience

• 7 Years relevant experience


• BS Degree in Engineering, biology/microbiology, chemistry, or related science field


• MS Preferred


• Previous project management experience preferred.

Knowledge: Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices. Specialized training in manufacturing operations, system design and development, terminal sterilization methods, industrial statistics, and technical writing preferred. Experience in project management tools are highly desirable.  Experience in working with Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting preferred.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company).  Solidworks, Minitab, and SAP or corporate ERP systems experience desirable.

Reasoning Ability: Develops solutions to a variety of complex problems.  May refer to established precedents and policies.

Discretion/ Latitude:  Work is performed under general direction.  Participates in determining objectives of assignment.  Plans schedules and arranges own activities in accomplishing objectives.  Work is reviewed upon completion for adequacy in meeting objectives.

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.