Senior Sterilization Specialist

Arthrex; Naples (FL); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Matching 401(k) Retirement Plan

Paid Time Off

Free Onsite Lunch

Job summary

Arthrex GmbH is seeking a Senior Sterilization Specialist at our Global Headquarters in Naples, FL. The role involves managing sterilization processes and ensuring compliance with quality standards.

Qualified candidates should have a Bachelor’s degree in a relevant science and at least 5 years of experience in sterilization practices. This position offers various benefits, including medical and dental insurance, a 401(k) plan, and paid time off.

Qualifications

• 5 years relevant experience in sterilization assessment of medical devices.
• Experience in manufacturing processes is preferred.
• Familiarity with Medical Device Risk Management (ISO 14971).

Responsibilities

• Lead sterilization and end-user reprocessing projects for quality systems compliance.
• Maintain corporate sterilization programs according to international standards.
• Conduct validations and testing in collaboration with laboratories.

Skills

Knowledge of FDA and ISO guidelines

Project management skills

Communication skills

Hands-on laboratory testing experience

Knowledge of terminal sterilization methods

Knowledge of orthopedic surgery principles

Education

Bachelor’s Degree in Biology/Microbiology, Chemistry

Tools

Microsoft Office Suite

Solidworks

Minitab

SAP or corporate ERP systems

Job description

Arthrex, Inc.is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex isactively searching for Senior Sterilization Specialist for our Global Headquarters in Naples, FL. The Senior Sterilization Specialist is responsible for Arthrex Inc’s Sterilization and end-user reprocessing projects, validations, and monitoring programs in accordance with quality systems requirements. 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 and Experience

• Bachelor’s Degree in Biology/Microbiology, Chemistry, or related science field required.
• 5 years relevant experience
• 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 required.
• Hands on experience performing 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.

Knowledge and Skill Requirements/Specialized Courses and/or Training

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

Ability to define problems, identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change. 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. 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 to 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.

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 Time Off
• 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.