Product Surveillance Specialist IV

Merz North America•Racine, WI

About The Position

The Product Surveillance Specialist IV performs day-to-day tasks and provides technical data assessment of post-market events. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist IV works with moderate supervision and requires a high degree of interaction with customers, health care professionals, and Global Merz employees at all levels within the organization.

Requirements

High School Diploma with 3 years of experience
Associate’s Degree with 1 year of experience
Customer Service Experience
Medical or Surgical Office Experience
Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
Basic medical and/or scientific terminology.
Organized with attention to detail.
Able to prioritize and manage multiple records/reports simultaneously.
Professional phone etiquette with the ability to appropriately handle sensitive information.
Good communication skills including written and verbal.
Ability to work with company staff and communicate effectively throughout the organization.
Experience with Microsoft Office Suite.
Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Responsibilities

Field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).
Provide technical support and remote troubleshooting guidance as needed.
Review associated records, 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.
Manage customer relationship and expectations during the course of the complaint investigation.
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.
Develop solutions to a variety of basic problems.
Support statistical analysis of complaint trends.
Support training program by completing assigned training in a timely manner.
Process Improvement Initiatives: Support operational changes to improve efficiencies in all aspects of complaint handling.
Support investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Compliance Initiatives: Support internal and external quality system audits.
Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
Employees will be required to follow any other job-related instructions and to perform any other job-related duties required by their supervisor.