Design Quality Engineer Sr. - Risk Management

 Requisition ID:                       60016                          Title: Design Quality Engineer Sr. - 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 Sr – 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:

• Develop and promote the Arthrex Risk Management processes for medical devices, including developing, managing and maintaining global policies and procedures.
• Create, manage, and maintain device risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements part of the device design process.
• Generate Event Risk Assessments (ERAs) to appropriately document and disposition patient and/or user health hazards arising from product complaints or non-conformances;
• Partner with Design Engineering and Program Management to ensure appropriateness and adequacy of quality management system documentation facilitating design and development planning and execution.
• Function as the global representative for Arthrex Risk Management process during Agency/3rd party audits.
• assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.
• Collect and analyze product design and quality data to facilitate generation of lessons learned, improvement of processes, and assurance of patient safety.
• Participate in program design reviews and ensure risk traceability to design requirements and risk mitigations are clearly documented and maintained.
• Provide guidance and support to design and manufacturing teams in the generation of risk source documentation, e.g., dFMEA, pFMEA, Fault Tree Analysis, etc

Education and Experience:

• Bachelor’s degree in Engineering or Engineering Technology required.
• 5 years’ experience in a regulated environment required.
• Experience in working with product risk management, CAPA, Complaint Management, and Nonconformance Reporting required

Knowledge and Skill Requirements/Specialized Courses and/or Training:

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.

Historical perspective on risk management programs and requirements preferred.

Personnel supervision experience 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

• Medical, Dental and Vision I