Medical Device Customer Quality Manager

Naples, FL
United States

Category
Experience Required
Yes
Degree Required
Yes
Employment Type
Full-Time
Work Schedule
Full-Time

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.