Quality Systems & Regulatory Compliance Specialist Sr.

Date: Sep 11, 2022

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 54859 
Title: Quality Systems & Regulatory Compliance Specialist Sr. 
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 and Regulatory Specialist, Senior who will support the Global CAPA Department to maintain and improve the Arthrex global Quality Management System (QMS), in compliance with FDA QSR, ISO 13485, and all other applicable regulatory requirements The successful candidate will have a Bachelors’ degree and 7 years relevant experience.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities: 

 

  • Organizes, documents, and coordinates ongoing projects in Quality Systems and Global CAPA to assure the Arthrex QMS meets all applicable requirements. 
  • Coordinates and Manages corrective and Preventive Actions (CAPA), Nonconformances (NCR), and/or Deviation Records with responsible parties to assure adequate compliance to Arthrex QMS requirements.  
  • Responsible for the review of CAPA, NCR, and/or Deviation Records, to assure compliance and completeness to the records. 
  • Generates/creates reports against determined measurement criteria within the QMS. 
  • Provide guidance to the users of QMS software/ procedures. 
  • Assist in writing and/or revision of Arthrex QMS documents. 
  • Supports Quality Systems training activities.  
  • Assists business/process owners with the development, revision, and review of QMS documents for compliance and completeness.  
  • Assists with cGMP/Quality System training to new and current employees.  
  • Performs Quality System data trending to assure applicable requirements and management goals are being met.  
  • Prepares presentations and related materials for CAPA Review Board and Management Reviews. 
  • Supports Internal and External Audits as CAPA, NCR SME   

 

Education and Experience: 

 

  • Bachelor’s Degree required, preferably in Engineering or Science Related study, or related area. 
  • Understanding of FDA’s Quality System Regulations (QSR) and ISO 13485 preferred. 
  • 7 years experience with Nonconformances, corrective and preventive actions, ISO 13485 

  

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

Working knowledge of ISO 13485 and 21 CFR part 820 – Quality System Regulations preferred. Experience in working with CAPA, Nonconformance Reporting, or Deviation Reporting highly desirable. 

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 Pilgrim Quality Data experience desirable. 

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, Orthopedic, ERP, SAP, Quality, Healthcare, Technology