QA Specialist II - Sterilization

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 a QA Specialist II, Sterilization for our manufacturing site in Ave Maria, FL. The QA Specialist II maintains Arthrex Manufacturing Inc (AMI) Sterilization Facility’s quality assurance program in accordance with Quality Systems Requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• Ensure proper and timely accurate completion of sterile load files of AMI products;
• Maintain the Sterile Release program for loads produced by AMI and ensure timely and safe product release to meet customer requests;
• Report and act by opening, disposition, evaluating, and closing on Non Conformances observed during sterilization processes for AMI to provide a resolution for the disposition of affected loads;
• Support the AMI Sterilization Facility Personnel to investigate Non Conformances related to sterilization processes in order to determine the root cause and prevent re-occurring issues;
• Support the AMI Sterilization Facility program to identify and encourage process improvement;
• Maintain procedures related to the Quality Assurance – Sterilization department activities and review procedures / records related to the AMI Sterilization Facility processes;
• Function as lead auditor and/or subject matter expert for quality management system audits of
• Arthrex’s sterilization service providers in accordance with applicable standards, e.g., ISO 13485, ISO 11135, ISO 11137 parts 1 and 2, and international regulatory directives;
• Generate and execute protocols for sterilization processes (i.e. EO, Gamma, X-Ray etc.) and equipment validation and re-validations, along with reports and conclusions;
• Manage all activities related to sterilization validations and/or testing, and directly interact with external and corporate laboratories, and sterilizers personnel to accomplish the assigned tasks;
• Assess devices for compatibility to proper sterilization modalities, e.g., radiation and ethylene oxide, by validating and/or adopting Arthrex manufactured products to established or new families using microbiological and sterilization theory and practice according to applicable ISO requirements;
• Effectively work within a cross functional team environment as both a champion and team member;
• Support Arthrex business and expansion goals;
• Must be able to travel domestically and internationally up to 10% of the time

• BS in STEM discipline
• 2+ years relevant experience

• Knowledgeable of FDA and ISO guidelines for the sterilization modalities of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of sterilization test systems requirements.
• Hands on experience managing sterilization product assessments and validations.
• Test protocol and report writing experience.
• Knowledge of ISO 13485 guidelines and principles of quality requirements
• Experience with CAPA processes and non-conformance investigation techniques to determine root-cause
• Knowledge and Skill Requirements/Specialized Courses and/or Training:
• Experience in project management, risk management (such as FMEA, FTA, FMECA) tools are highly desirable. Experience in working in Medical Device industry, CAPA, Complaint Management, and Nonconformance Reporting required.

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). SAP and / or Pilgrim Quality Data experience desirable.

Ability to 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.

Ability to comprehend and apply mathematical principles to the degree required…