Medical Device Customer Quality Manager

Naples, FL
United States

Experience Required
Degree Required
Employment Type
Work Schedule

Job Description

Live and work in paradise!

We have an awesome, high visibility leadership opportunity for a dynamic Product Surveillance / Complaints Manager at the Arthrex corporate headquarters in Naples Florida. We are seeking a transformational leader that has a passion for continuous improvement and world class performance. If you have a bachelor’s degree (Engineering preferred), 3 years or more of proven complaint handling excellence in a Medical Device setting, and at least 2 years of team leadership distinction, apply now and experience life on Florida’s paradise coast!

Main Objective:

Ensure compliance in the areas of complaints, consisting of but not limited to; FDA Med Watch filing, CMDCAS Adverse Event filing, MDD Vigilance Reporting.

Essential Duties and Responsibilities:

  • Supervises and directs the efforts of the Complaints Department
  • Reviews and approves complaints and complaint closure letters
  • Responsible for the coordination of worldwide complaint data into appropriate management reports, analyzing trend data associated with complaints, drawing appropriate conclusions to trend data and presenting such data in a meaningful, usable format to management
  • Responsible for interfacing with customers, distributors and doctors regarding complaint issues
  • Participate in Management Review Meetings to disseminate complaint data
  • Responsible for assuring the integrity and completeness of Complaint Files
  • Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the Complaints Department
  • Responsible for maintaining procedures and practices related to complaint handling to assure compliance with ISO and FDA regulations
  • Responsible for assuring timely review and closure of complaints
  • Responsible for assuring complaints personnel are properly trained in all procedures and SOPs
  • Responsible for maintaining efficient work flow, work assignments and throughput
  • Responsible for participating in FDA and ISO audits, as well as other 3rd party inquiries as required.

Education and Experience:

  • Bachelor’s degree required in engineering (preferred), business, regulatory, compliance or related areas.
  • 3 years senior level experience in handling complaints in an FDA /ISO regulated environment.
  • 2 years of management experience.

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

Knowledge of FDA and ISO regulations regarding complaints and reportable events, excellent proven interpersonal skills in dealing with all levels of professionals

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word, PowerPoint (or equivalents if changed by the Company). SAP and / or Pilgrim experience desirable.

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.