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Product Surveillance Compliance Specialist in Naples, FL ,  at Arthrex

Date Posted: 2/3/2018

Job Snapshot

  • Employee Type:
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Requisition ID:
Product Surveillance Compliance Specialist
Arthrex, Inc.
INC- Naples, FL

Main Objective:

Review complaint files for accuracy and thoroughness to determine eligibility for closure.  Review complaint file investigations and close complaints in a consistent, uniform and compliant manner.

Essential Duties and Responsibilities:

  • Review all product complaint investigations on a timely basis to meet closure goals
  • Evaluate product complaint documentation for completeness and consistency
  • Analyze historical complaints for consistency in evaluation, documentation and closure
  • Manages, assembles and maintains standard closing statements
  • Responsible for uniformity in all user selected descriptions and information on all complaints
  • Works with Product Surveillance Specialists to resolve discrepancies in complaint files
  • Trains Product Surveillance Specialists on proper methods to document complaint file information
  • Works with various Engineering teams to review and conduct proper complaint investigations
  • Works with leadership to improve and maintain the closing process for all complaints
  • Responsible for developing, maintaining, and producing reports from the Complaint software application

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 required.

Experience working in a regulated industry such as medical device, pharma, defense, etc. strongly preferred.

Experience conducting investigations towards root cause and/or reviewing investigations is preferred.

Experience working with personnel of various skills sets and education levels; able to interface with personnel across multi-functional departments preferred.

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

Complaint investigation training under FDA cGMPs/QSR and ISO 13485 QSR preferred.

Must have good analytical skills and logic skills, and experience with business or technical writing preferred.

Machine, Tools, and/or Equipment Skills:

Intermediate PC and Microsoft Office skills.

Above average or advanced Microsoft Excel skills strongly required.

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.

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.