• Quality Assurance Manager II (Design Quality)

    Abbott (Abbott Park, IL)


    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.

     

    **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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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

    + Bachelor's Degree preferred in a technical/scientific discipline or closely related field. Equivalent work experience in a similar position may be substituted for minimum educational requirements.

    + 6 - 10 years experience preferably in a quality/ technical area or clinical laboratory.

    + Demonstrated leadership experience through formal and/or informal assignments is preferred.

    + Knowledge of regulations and standards affecting IVDs and Biologics.

    Preferred Qualifications

    + Candidates should have a sound fundamental understanding of regulatory inspections and quality systems.

    + Ability to serve as a Quality Advisor, Consultant, or Subject Matter Expert including:

    + Design Quality and Design planning including assay development, stage gate process (product life cycle) and deliverables.

    + Represent Abbott TM Design Quality in both internal and external audits.

    + 5+ years of responsibility for direct reports.

    + Ability to have significant interaction with executive management with accountability for assigned projects.

    + Proven technical capabilities covering serology, NAT, and commodity/consumable technology.

    + Alinity s experience.

    + Project leadership with an emphasis in Inspection Management and Regulations.

    **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** https://abbottbenefits.com/ (http://www.abbottbenefits.com/pages/candidate.aspx)

     

    Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

     

    Connect with us at abbott.com , on LinkedIn at https://www.linkedin.com/company/abbott-/ , and on Facebook at https://www.facebook.com/AbbottCareers .

     

    The base pay for this position is $111,300.00 – $222,700.00. In specific locations, the pay range may vary from the range posted.

     

    An Equal Opportunity Employer

     

    Abbot welcomes and encourages diversity in our workforce.

     

    We provide reasonable accommodation to qualified individuals with disabilities.

     

    To request accommodation, please call 224-667-4913 or email [email protected]