Sr. Manager, Post Market

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.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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.

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

The Opportunity

This position is located out of our Burlington, Massachusetts location in our Abbott Heart Failure Division. Abbott Heart Failure helps those with heart failure survive and thrive, bringing together exception teams to pioneer and increase access to lifesaving connected innovations.

This position of Senior Manager, Post Market works within our Quality team supporting all parts of Abbott Heart Failure. This role has responsibility for complaint handling and is process owner for investigation of product. This role will be the subject matter expert, work closely with Commercial, Operations, and Design teams, and interact with regulatory agencies and customers to ensure the division follows global complaint handling procedures and regulations.

This position is responsible for implementing and maintaining the effectiveness of the quality system including personnel development and assessing performance. Providing direct and indirect supervision to professional, direct or indirect labor staff to ensure that complaints are handled in accordance with global regulations. The position ensures that compliance is maintained and that employees are trained and following the required divisional and Abbott policies and procedures. The Senior communicates with  Senior and Executive management in the area of complaints handling and issues affecting product performance and anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Identifies and recruits staffing / resources to support complaint handling activities and on-market support for multiple product lines deemed critical to success of financial performance for the Division.

• Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization.

• Ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements.

• Champions and actively participates in development / improvements of complaint handling processes and procedures.

• Responsible for ensuring that customer complaints are reviewed in a timely manner and elevated to the medical events group as necessary to meet reporting regulations.

• Responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system.

• Monitor incoming complaints for increasing trends and alert management when a product issue is emerging.

• Participate in monthly tracking and trending meetings - provide in