Quality Engineer II Manufacturing Quality Systems

Date: Jul 27, 2022

Location: Ave Maria, FL, US, 34108

Company: Arthrex

Requisition ID: 54406 
Title: Quality Engineer II Manufacturing Quality Systems 
Division: Arthrex Manufacturing Inc (US02) 
Location: Ave Maria, FL









Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Quality Engineer II, Manufacturing Quality Systems who is responsible for supporting the Manufacturing Quality Systems Supervisor with all quality related support for improving and maintaining the Arthrex Manufacturing site Quality Management System to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements. A Bachelors’ degree in an Engineering discipline will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This is an in-office position located in Ave Maria, Florida; it is not a remote position.


Essential Duties and Responsibilities:

  • Responsible for participating in QS projects and assuring the Arthrex QMS meets all requirements.
  • Responsible for reviewing root cause analyses, effectiveness review plans and NC/CAPA documentation for Arthrex QMS compliance.
  • Work with Arthrex QE’s to improve quality and assist, where necessary, in CAPA investigations.
  • Train and/or assist Manager – QS Supervisor in the training of QE’s and Subject Matter Experts (SME’s) on Arthrex QMS procedures, root cause analysis, effectiveness review planning and QMS software / programs.
  • Participate in Internal and External quality audits as directed by the QS Supervisor.
  • Responsible for writing and/or assisting in the writing of Arthrex Manufacturing site QMS SOPs.
  • Responsible for assisting/leading NCR or CAPA investigations.
  • Responsible for assisting in compiling and reporting on Arthrex QMS / Compliance metrics.
  • Responsible for writing and/or assisting in the writing of audit responses, both Internal and External.


Education and Experience:

  • Bachelor’s degree in an Engineering discipline required. 
  • 2 years experience in a Quality Control or Quality Assurance position required; preferably in a Medical Device Company.


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

Knowledge of testing equipment, statistical methods, control plans.

Experience in leading CAPA activities, specifically root cause analysis and effectiveness review planning.


Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), Agile, SAP or similar inventory software as well as CAPA, NCR, Audit or Complaint Management software.


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: Medical Device Engineer, Manufacturing Engineer, Medical Device, Quality Engineer, Systems Engineer, Engineering, Healthcare