Design Quality Engineer - Risk Management, Sr. I

Date: May 6, 2022

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 53668 
Title: Design Quality Engineer - Risk Management, Sr. I 
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 – Risk Management, Senior I who will support risk management programs with an emphasis on patient safety and harm reduction. 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 and 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:

  • BS Degree in Engineering or Engineering Technology required 
  • 5 Years’ experience in a regulated environment 
  • MS Preferred. 
  • Previous project leadership experience required. 

 

Skills and Knowledge:

  • Knowledgeable of Regulatory and ISO guidelines for the development of medical devices required. 
  • Experience in working with product risk management, CAPA, Complaint Management, and Nonconformance Reporting 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 are highly 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.   

 

 

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.


Nearest Major Market: Naples

Job Segment: Quality Engineer, Medical, Orthopedic, Manager, Engineering, Healthcare, Management, Quality