Quality Assurance Manager II (Design Quality)

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:

Manager Quality Assurance II (Design Quality)

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 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
This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine (TM), Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. 

The Manager Quality Assurance II (Design Quality) will provide leadership, oversight, and project management covering new product development and on-market design changes as related to Abbott's Quality System for assays and commodity/consumables for the Alinity s platform and any future TM platforms. This includes division / business support, quality/regulation expertise and consulting activities.

As the Manager Quality Assurance II (Design Quality), you’ll have the chance to provide leadership for pre-inspection, during inspection, and post inspection support. This support encompasses internal and external inspections Core Dx Transfusion Medicine within Abbott as well.

What You’ll Work On

• Provide design quality leadership and direction for new product development and on-market design changes of Transfusion Medicine assays and commodities following the Core Dx Quality System.

• Direct reports include 6-9 individuals. Indirect reports include 2-6 individuals. 

• Build and maintain a strategic work force while mentoring direct reports and providing growth opportunities to support talent management pipeline.

• Provide constructive feedback and guidance to direct reports.

• Participate and/or lead Quality Plan Projects/Quality Project focused on quality system and GMI initiative. Provide direct business/division support. Participate in new and change regulation review for business impact. 

• Engage and interaction with senior leadership and key stakeholders across the division and accountability for assigned projects.

• Work collaboratively with peers throughout TM R&D, Operations, Regulatory, PMO, Commercial, Finance, etc.

• Provide support, consultation and direct interface during internal and third-party inspections including the identification and review of outstanding issues/potential audit risks, mock audit training, and promoting effective and professional inspection readiness activities.

• Improve the effectiveness of the Abbott Quality System, including monitoring, trending, and analysis of Abbott compliance performance.

• Assessing, and providing meaningful feedback regarding compliance status, effectiveness of the team, and related quality and operational systems.

• Provide scheduling and detailed project tasks for reports to ensure milestones are implemented.

• Review and support creative solutions to key topics and utilize risk management principles.

Required Qualifications