Complaints Handling Manager, U.S. Region - Columbus, OH

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 122,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. Our Nutrition business develops science-based products for people of all ages—from helping babies and children grow to keeping adult bodies strong and active. Millions around the world rely on our leading brands, including Similac, Pedia Sure, Pedialyte, Ensure, and Glucerna, 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 the FreeU education benefit—an affordable and convenient path to earning a bachelor’s degree.
• Recognition globally as a great place to work, and for diversity, working mothers, female executives, and scientists.

This position works out of Columbus, OH in the Nutrition Division. The Complaints Handling Manager, U.S. Region will implement quality standards, ensure and execute compliance on every stage of the process. Manage the complaint handling quality system for product manufactured in/shipped to the U.S. and the Complaint Laboratory in the U.S.

• Develop and implements quality assurance policies, strategies and regulations related to laboratory and complaint handling in the U.S.
• Assesses potential risks, ensures compliance and gives recommendations.
• Takes responsibility and manages team for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, finished product or services).
• Facilitates audits, agency complaints, and regulatory inspections related to product manufactured in/shipped to the U.S.
• Respond to audit findings.
• Works with broad group of internal cross functional partners to ensure compliance, positive investigation outcomes, and timely execution.
• Meet with customers and HCPs (Healthcare Providers), as needed.
• Escalate complaints and investigation outcomes appropriately.
• Participate in on market evaluation process.
• Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
• Coordinates quality trainings.
• Prepare, develop, monitor, and report on monthly, quarterly, and annual metrics related to area of responsibility.
• Perform ongoing complaint monitoring and data trending related to product manufactured in/shipped to the U.S.
• Provide timely feedback on complaint inputs and investigations.
• Process, assess, and approve complaints related to product manufactured in/shipped to the U.S; prepare written responses.
• Develop and provide feedback on complaint handling standards.
• Initiate and investigate CAPAs when necessary.

• Bachelor's Degree (± 16 years).
• Food Science, Engineering, Microbiology, Biology, or Chemistry.
• Minimum 7 years.
• Food and Infant Formula industry, leading a team with little direction, quality system ownership, and laboratory.
• Experience with in a manufacturing…