Product Surveillance Specialist IV - Quality, Compliance & Impact
Merz Aesthetics, Racine, WI, United States
About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.
A Brief Overview
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.
What You Will Do
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. 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.
Minimum 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
Technical & Functional Skills
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.
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!
This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.
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Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.
A Brief Overview
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.
What You Will Do
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. 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.
Minimum 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
Technical & Functional Skills
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.
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!
This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.
#J-18808-Ljbffr