Job Title: Product Surveillance Associate
Job Location: Sturtevant, WI 53177
Job Duration: 12 months

• The Product Surveillance Specialist 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 works with moderate supervision and requires a high degree of interaction with customers, health care professionals, and Global employees at all levels within the organization.

• 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.
• 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.
• 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.

• High School Diploma with 3 years of experience, or Associate's Degree with 1 year of experience.
• Customer Service Experience. (Preferred)
• Medical or Surgical Office Experience. (Preferred)

• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. (Preferred)
• Basic medical and/or scientific terminology. (Preferred)
• 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.