Sr. Quality Systems, Project Manager

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 Plymouth, 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.

As the Sr. Quality Systems, Project Manager, you’ll have the chance to manage global programs and support effective and compliant implementation of ongoing projects into Division's Quality Management System. Develop long term strategies to meet division goals. Present program strategies and updates to executive management and stakeholders. Division Subject Matter Expert (SME) for quality systems and/or subsystems and/or division processes. Incumbent may be a division Process Owner for quality system processes, examples include but not limited to: Production and Process Control subsystem SME, Validation Process Owner, Process Monitoring Process Owner, etc. Directs multi-site, Division-wide activities to accomplish quality system objectives and goals.

What You’ll Work On

• Functions as the SME for a division quality system, quality subsystem, or process.
• Identifies and recruits project/program resources to support divisional scope, multi-site quality system projects/programs and manages division-level teams to achieve Division QA project/program-related goals and strategic initiatives.
• Represents and champions Division causes, products, services and quality systems to U.S. and non-U.S. regulatory bodies.
• Frequently represents Division during internal and external inspections such as FDA, ISO, and AQR.
• Interprets regulations and requirements and implements programs and procedures to meet these requirements worldwide.
• Primary division contact for domestic/international sites and affiliates regarding quality subsystems and processes.
• Collaboratively supports Directors, Quality Subsystem Owners, and other internal and/or external stakeholders with organizational, project/program management.
• Identify metrics to consistently measure program status and effectiveness of implemented solutions.
• Create appropriate messaging and dashboards to facilitate global communication to all levels of the organization.
• Forecast and communicate resource needs to ensure program success while maintaining appropriate cost levels.
• The above statements are intended to describe the general nature and level of work being performed, other duties may be performed as assigned.
• It is expected that the individual will interact frequently with Division Management with executive responsibility, and therefore requires a high level of competence, confidence and credibility.
• Strategic and tactical decisions for the Division will be made based upon the information that th