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.

Senior Product Performance Analyst

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a high employer contributionTuition 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN, location for our Electrophysiology business.  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.

The Sr Product Performance Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining 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 to various teams (e.g. Regulatory, Quality Engineering).

What You’ll Work On

Initiates and manages the complaint fileMaintains accurate entry of complaints in the databaseCommunicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices)Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaintsIndependently 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, consulting as needed with managementPrepares customer letters with investigation findingsIs diligent of any unusual trends in product complaints and communicates them to managementParticipates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings)Archives complaint records and retrieves information on closed investigationsEnsures accurate department procedures and work instructions are maintainedTrain new employees to the complaint handling processProvide support to the Legal Department regarding product complaintsSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsPerforms other related duties and responsibilities, on occasion, as assignedPostmarket Surveillance Analyst (product evaluations):Performs product evaluations in a timely mannerExecutes product evaluations to develop a well-documented and accurate root cause evaluationCoordinates product evaluations with other departments and external consultantsUse procedures, judgement and experience to determine appropriate testing of returned products with minimal guidanceReviews all pertinent information to complete the evaluation (e.g. photos, study or log files, field service reports, external investigations)Interprets/reviews technical product specifications, measurements and the Device History RecordPrepares technical reports of findings and enters them into the complaint systemReviews external vendor/consultant evaluations and enters them into the complaint systemMaintains work area in clean and orderly condition and adheres to safety and biohazard proceduresIs diligent of any unusual trends in product evaluations and informs managementIndependently assesses the evaluation results to determine if they meet regulatory reporting guidelines and inform the appropriate Postmarket Surveillance team member of the findingsParticipates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings)Adheres to the device retention and disposal proceduresEnsures accurate department procedures and work instructions are maintainedCollaborate independently with other team members and departments needing product evaluation informationBe able to ascertain when additional support may be needed from other teams based on product evaluation findings (e.g. potential manufacturing-related issues)Train new employees to the product evaluation processSupports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirementsComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments 

Required Qualifications

Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.Solid understanding and application of business concepts, procedures and practices.Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit.

What We Offer

At Abbott, you can have a good job that can grow into a great career. We offer:

A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communities

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.

The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.