Product Surveillance Associate I

About the Company: Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Product Surveillance Activities:

• 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.
• 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.

Process Improvement Initiatives:

• Recommend operational changes to improve efficiencies in all aspects of complaint handling.

Adherence to Regulations:

• Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report. Required
• Support the submission of MDRs and Vigilance Reports according to regulatory timelines.
• Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting. 

Education:

• Associate’s Degree required in nursing, pharmacy, medical technology, engineering or scientific background ( Bachelor’s Degree in nursing, pharmacy, medical technology, engineering or scientific background. Preferred

Professional experience:

• Medical Device. Preferred
• Medical or surgical office experience. Preferred
• Customer service experience. Preferred

Knowledge, skills and abilities (incl. languages):

• Prioritizing and managing complaint reports.
• Microsoft Outlook, Word, Excel, PowerPoint.
• Medical and/or scientific terminology. Required
• Professional phone etiquette plus careful handling of sensitive information. Required
• English fluency (read, write). Required
• SmartSolve. Preferred

Personal skills:

• Organized, attention to detail. Required
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization. Required

Must be able to pass vision testing requirements (with or without corrective eyewear).

• 20/20 Near Acuity Vision

Benefits:

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period! Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Quality