Senior Project Lead Quality Assurance - Columbus, OH

About this role

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Senior Project Lead Quality Assurance

Working at Abbott Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

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 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 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 Our location in Columbus, OH currently has an opportunity for a Project Lead Quality Assurance.

As a Senior Project Lead within QA, the individual will be responsible for supporting the complaint management quality system.  In this role the individual will be r esponsible for tracking, trending, analytics, and metric reporting for global complaint data. Additionally, the individual will be expected to develop into a division SME for complaint management; identify and lead process improvement projects for our complaint handling process; and oversee the data used in the complaint handling process to drive compliance.  The candidate must be capable of working under general direction while leveraging input from manager and stakeholders. The candidate must demonstrate the willingness to learn the business, challenge the status quo and balance priorities while keeping a positive and inquisitive mind-set.  The role is critical in sustaining the business’s ability to appropriately process complaints, analyze complaint data, and detect potential signals for AN product on market (globally).

WHAT YOU’LL DO   • Perform routine tracking and trending for complaints. Evaluate complaint data to make proposals and decisions. Elevate concerns appropriately. • Review trending decisions and investigations. • Complete metric reporting with a high level of accuracy. • Lead department trend meetings. • Create QRs in ABTRAQ for tracking and trending. • Develop, design, and run reports and data to fulfill ad hoc requests. Determine the best approach for extracting data to fulfill requests. • Establish annual complaint thresholds using statistical data analysis. • Own PowerBI and COGNOS reports. Offer improvement recommendations to streamline and simplify. • Work with IT to plan and execute validation changes and proposed changes. • Perform user acceptance testing for IT systems supporting complaint management such as Trackwise, DataMart, and Power BI. • Support the development of user requirements for IT systems, reports, and databases. • Help users obtain access to owned systems and maintain user groups. • Register agency complaints as needed. • Understand the full complaint process including review and approval of access requests. • Monitor data to ensure it is correctly loaded. If discrepancies are found, follow through with clean up and ensure correct information is reloaded. • Initiate IT tickets to correct data loading errors and notify impacted users • Demonstrate basic project management skills by acting as a project lead on small to medium, well defined projects. • Provide guidance to less experienced staff. • Plans, organizes, and prioritizes own daily work routine to meet established schedule. • Exercises authority and judgment within defined limits to determine appropriate action. • Oversees operational implementation of quality assurance strategies. • Completes the assessment of potential risks, ensures compliance, and gives recommendations to management. • Participates in audits and regulatory inspections. • Makes recommendations for continuous improvement opportunities with data reports and modeling. • Identifies opportunities to improve the efficiency and effectiveness of the systems and processes being examined (process improvement/reengineering projects). • Provide training and feedback to the business for PowerBi reports and procedurally driven initiatives. • Maintain Division complaint responsibilities for the database used for FDA reporting • Manage available sites and corresponding data in the DataMart (adding and removing new sites and lines)

Required Qualifications • Bachelor’s Degree in Data Analytics, Statistics, Engineering, or equivalent. • 1 - 3 years of Experience with Power BI, Minitab, and other data modeling and data analytics tools. • Demonstrated performance and results in continuous improvement efforts and risk reduction. • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. • Ability to work effectively within a team in a fast-paced changing environment. • Strong verbal and written communications with ability

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