Quality Systems Specialist Lead

Date: Jan 4, 2023

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 57269 
Title: Quality Systems Specialist Lead 
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 Quality Systems Specialist Lead who will actively monitor Quality Management Systems (QMS) processes, ensuring the effective implementation of these processes including change control, document control, control of records, CAPA/NCR coordination, and auditing support.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.


Essential Duties and Responsibilities: 


  • Proactively identify and help implement improvements to applicable QMS processes and related systems/software.  
  • Monitor applicable QMS processes, promoting high-quality standards, acceptable productivity levels, and a standardized approach across all locations. 
  • Train new employees in all applicable processes. 
  • Contribute towards achieving departmental process efficiency goals. 
  • Interface with internal and external resources, including auditors, regulatory entities, engineering, marketing, regulatory, supply chain, and other departments to accomplish goals and ensure effective process implementation. 
  • Assist in assuring that systems and personnel keep pace with new requirements, techniques, workflows, and increased volume. 
  • Research and resolve business transaction conflicts. 
  • Maintain a current knowledge of current regulations and standards affecting the department. 
  • Provide status reports related to quality and productivity goals. 
  • Participate in internal and external QMS audits and inspections as a department representative. 
  • Cover various department functions during times of short staff or as needed to ensure productivity meets goals. 


Education and Experience: 

Bachelor’s Degree required, preferably in a Science related field 

Minimum of five years of relevant experience in a Medical Device Company, including working knowledge of applicable QMS processes.  


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

Strong project management and analytical skills. Ability to collaborate effectively with team members and stakeholders. Demonstrated ability to consistently meet deadlines. Strong problem-solving skills and motivation for continuous improvement. Attention to detail. Excellent interpersonal and communication skills are essential. 


Machine, Tools, and/or Equipment Skills: 

Working knowledge of enterprise software systems (such as SAP) and quality management systems.  Proficient in MS PowerPoint, Excel, MS Word. 


Reasoning Ability: 

Ability to define problems, collect data, establish facts, and draw valid conclusions.  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. 







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, Document Control, Supply Chain, CAPA, Healthcare, Administrative, Quality, Operations, Management