Product Surveillance Specialist IV (Security)
About the Company:
Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in Wisconsin manufacture, package, and ship several innovative products so that people all over the world can live better, feel better, and look better.
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.
Key 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.
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.
Other Duties:
- Employees will be required to follow any other job-related instructions and to perform any other job-related duties required by their supervisor.
Education:
- High School Diploma with 3 years of experience, or Associate's Degree with 1 year of experience. Required
- Customer Service Experience. Preferred
- Medical or Surgical Office Experience. Preferred
Experience:
- 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. Required
- Organized with attention to detail. Required
- Able to prioritize and manage multiple records/reports simultaneously. Required
- Professional phone etiquette with the ability to appropriately handle sensitive information. Required
- Good communication skills including written and verbal. Required
- Ability to work with company staff and communicate effectively throughout the organization. Required
- Experience with Microsoft Office Suite. 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 also valuing our employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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For further information, please review the Know Your Rights notice from the Department of Labor.
Quality
