Product Surveillance Specialist I

Arthrex•Pelican Bay, FL

1d•Remote

About The Position

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 Product Surveillance Specialist I to join our team. The Specialist I will process the initial intake of customer complaints via phone, email, and fax in compliance with FDA Quality System Regulations through documentation and maintenance of records using established procedures. They also help to Resolve non-complaint related customer issues in a timely and professional manner. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™. This position is eligible for remote work.

Requirements

High school diploma or equivalent required
Proficiency in the use of PC and MS Office programs, particularly MS Excel and MS Word required.
Ability to learn new programs that facilitate complaint handling and adverse event reporting.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of writings, communications, situational issues, customer concerns, and be able to deal with several abstract and concrete variables.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
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.

Nice To Haves

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

Responsibilities

Professionally handles incoming phone calls and emails and enters information into the complaint handling application accordingly.
Ensures all information from the initial contact is accurately captured and entered into the complaint handling application.
Interfaces with external customers such as distributors, sales reps, and various medical professionals to ensure customer issues are processed towards resolution in a timely manner.
Interfaces with internal departments such as Service, Technical Support, Sales & Contracts, and Product Management to ensure customer issues are processed towards resolution in a timely manner.
Works with vendors and OEMs to resolve customer issues in a timely manner.
Assists Product Surveillance Analysts with information gathering for complaint investigations.
Prepares closing letters when requested by customers.
Participate in FDA and ISO audits as required.