QA Engineer II - Manufacturing Quality Systems

Date: Sep 3, 2021

Location: Ave Maria, FL, US, 34142

Company: Arthrex

Requisition ID: 49598 
Title: QA 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 QA Engineer II - Manufacturing Quality Systems that works directly with the Manufacturing and Engineering teams within Arthrex. You will be responsible for ensuring the suitability and effectiveness of the Arthrex manufacturing site QMS by measuring and monitoring process effectiveness, driving and implementing improvements to QS processes, facilitating CAPAs and CAPA Review Board, administration and maintenance of internal and external audits, investigation/resolution of quality issues, and development of QS processes. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering or Engineering Technology 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™.


Essential Duties and Responsibilities:

  1. Responsible for participating in QS projects and assuring the Arthrex manufacturing site QMS meets all requirements.
  2. Responsible for reviewing root cause analyses, effectiveness review plans and NC/CAPA documentation for Arthrex manufacturing site QMS compliance.
  3. Work with QE’s to improve quality and assist, where necessary, in CAPA investigations.
  4. Train and/or assist QS Supervisor in the training of QE’s and Subject Matter Experts (SME’s) on Arthrex manufacturing site QMS procedures, root cause analysis, effectiveness review planning and QMS software / programs.
  5. Participate in Internal and External quality audits as directed by the QS Supervisor.
  6. Responsible for assisting in maintaining External Audit files in accordance with established procedures and SOPs.
  7. Responsible for writing and/or assisting in the writing of Arthrex manufacturing site QMS procedures and work instructions
  8. Responsible for assisting/leading NCR or CAPA investigations.
  9. Responsible for assisting in compiling and reporting on Arthrex manufacturing site QMS / Compliance metrics.
  10. Responsible for writing and/or assisting in the writing of audit responses, both Internal and External.
  11. Other duties as assigned


Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.


Education and Experience:

  • Bachelor’s degree in an Engineering or Engineering Technology discipline required. 
  • 2 years experience in a Quality Systems 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: Quality Engineer, QA Engineer, Medical, Orthopedic, Engineering, Healthcare, Manufacturing