Posted in General Business 30+ days ago.
Type: Full-Time
Location: Naples, Florida
Requisition ID: 60047 Title: Design Quality Engineer II - Risk Management Division: Arthrex, Inc. (US01) Location: Naples, FL
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 Design Quality Engineer II - Risk Management whose responsibilities are to manage specific aspects of the Arthrex risk management program with an emphasis on patient safety, and harm reduction. This position will play a critical role in the risk management efforts. In coordination with the others in the department, this role will design, coordinate, and maintain various aspects of the patient safety and risk management programs for. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required.
Manufacturing process knowledge preferred.
Project management and communication skills training preferred.
Working knowledge of risk management requirements.
Working knowledge of device clinical use and associated harms and hazards • Knowledge of orthopedic surgery principles, theories, and products preferred.
Experience in project management, risk management (such as FMEA, FTA, FMECA) tools
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). SAP and / or Pilgrim Quality Data experience desirable.
Reasoning Ability : 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.
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.
Arthrex 2024 Benefits
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.
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