Quality/Customer Support Specialist (Medical Device)

Come join our team! Leading, global aesthetics company, and award-winning portfolio of injectables, devices and skin care products.

Location: Franksville, WI - 100% Onsite. Call center environment. There is no remote option.

Pay: $20

Job Overview: Provides clinical and safety data assessment of post-marketing events.  This position plays an integral role to maintain compliance with global regulations.  Works with minimal supervision and requires a high degree of interaction with customers, health care professionals, global government agencies and Global company employees at all levels within the organization.

Essential Duties and Responsibilities: 

• Field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s).
• Provide technical support and remote troubleshooting guidance as needed.
• Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
• Conduct periodic follow-up to close complaints in a timely manner.    
• Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure. 
• Support statistical analysis of complaint trends.
• Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.  Additional responsibilities may include submitting MDRs and Vigilance Reports according to regulatory timelines.
• Monitor the FDA’s MAUDE data base and provide quarterly reports of activity for management review.
• Recommend operational changes to improve efficiencies in all aspects of complaint handling. 
• Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.

Requirements:

• Associate’s Degree in nursing, pharmacy, medical technology, engineering or scientific background preferred 
• Recent BS/BA graduates encouraged to apply.
• Previous experience working in a Customer Service or similar role required, preferably with extensive phone experience on the phone.
• Medical or Surgical office experience preferred.  
• Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)
• Competent in identifying and responding to priorities and managing complaint related reports that must be submitted by remote sites and/or sales staff. 
• Knowledge of, and competent with, administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology. Solid grasp of Medical Terminology and competence with the English language as well as word definitions, composition, and grammar is required. 
• Ability to establish priorities, work independently, and proceed with objectives with minimal supervision. Ability to manage multiple priorities.  
• Handle communications with customers and patient information with tact and handle confidential information with discretion.

Additional Notes:

• Fresh grads with strong communication and experience in a customer service/retail type of position would be ideal.
• 70% of complaints that come in are on the device side - this is why an Engineering or a Physical Science degree is preferred
• Answering phones from clinics that have equipment and will have to do some of the troubleshooting on the equipment as well as file the complaint according to regulations