Quality Engineer II Product Surveillance, Quality Field Event Management

 Requisition ID:                       60903                          Title: Quality Engineer II Product Surveillance Field Safety 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 an Engineer II, Quality Field Event Management who is responsible for driving product improvements through performing and supporting product quality complaint evaluations and field safety communications. The ideal candidate will have a Bachelor’s degree in Engineering and 2+ years’ experience with root cause analysis, project management and continuous improvement in a regulated environment.

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 Product Surveillance processes for medical devices, including developing, managing and maintaining global policies and procedures.
• Perform root cause analysis for returned complaint devices or identified trends as appropriate.
• Maintain test protocols to evaluate returned product according to established specifications and record detailed results. Perform device evaluations when needed.
• Partner with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering teams to drive continuous process and product improvement.
• Function as the global representative for complaint investigation, escalation, and trending processes during Agency/3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.
• Provide timely customer feedback to key stakeholders through root cause analysis, statistical analysis and regularly scheduled forums.
• Support global complaint triage, intake, evaluation, reporting, investigation, closure and trending activities.
• Manage supplier relationships from initial notification to receipt of a supplier complaint evaluation.

Education and Experience:

• Bachelor’s degree in Engineering or Engineering Technology required.
• 2+ years’ experience with root cause analysis, project management and continuous improvement in a regulated environment.

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

• Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required.
• Knowledgeable of medical device complaint handling and adverse event reporting requirements preferred.

• Knowledgeable of product risk management, CAPA, and Nonconformance Reporting preferred.
• Knowledgeable of orthopedic medical devices including implants, instruments, biologics, and electronical equipment 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).  SAP and / or SmartSolve Quality Data experience desirable.