Product Performance Analyst I

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our St. Paul, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

Overview:

Under the direction of the department manager, the Product Surveillance Analyst may perform two different functions within the complaint handling. One role would be that of complaint investigation management and includes all activities pertaining to product complaints for SJM. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering). 

 

Another role of the Product Surveillance Analyst is that of performing evaluations of returned complaint products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings and customer letters, operating and maintaining the Product Surveillance Laboratory and equipment, and collecting and evaluating analysis data. The Product Surveillance Analyst will also be able to perform trending of complaint data in either role as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department Data Analyst. Depending on the site location of the PS Analyst, they may perform both complaint investigations and product analysis.

What You’ll Work On

• Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
• Investigates complaints/events in a timely manner.  Maintains accurate entry of complaints in database.  Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes.  Prepares customer letters with findings.  Records condition of returned products including observations, photographs. Coordinates product testing/analysis with other departments and external consultants.
• Prepares technical reports of analysis/findings--Tracks returned products within