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.

Essential Duties and 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.

Education and Experience:

• High school diploma or equivalent required
• Experience working in a regulated industry such as medical device, pharma, defense, etc. preferred

Machine, Tools, and/or Equipment Skills:

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.  Experience using SAP strongly preferred.

Reasoning Ability:

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.

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required to sit, use hands and fingers to handle or feel, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.  Specific vision abilities required by this job include close vision.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.