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 115,000 colleagues serve people in more than 160 countries.

　　Professional Quality

　　About Abbott

　　Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

　　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 (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 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 Dallas, TX location in the Core Lab Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

　　As the Professional Quality , you’ll conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business.

　　What You’ll Work On

　　Ensure that facilities, utilities, and equipment (FUE) used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.

　　Coordinate validation activities with other engineering disciplines, departments, and contractors.

　　Estimate, plan and review own and others work products.

　　Review documentation for accuracy, clarity, consistency, completeness, and compliance for multiple projects. Plans and performs assignments with a wide degree of difficulty.

　　Analyze data, procedures, and requirements with consideration given to financial and business outcomes.

　　Coordinate activities across impacted groups. Accepts ownership and responsibility for decisions.

　　You’ll be accountable for ensuring that FUE systems used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.

　　Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.

　　Provides compliant solutions to a variety of problems of moderate scope and complexity.

　　Interacts constructively with employees, managers, and cross-functional peers.

　　May lead a project with a limited scope, but usually a contributor on broader projects.

　　Provides guidance to other Professionals and Technicians.

　　Quality System Compliance -Maintains awareness of standards that regulate our industry.

　　Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.

　　Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

　　Risk Management - Applies basic Risk Management principles to work.

　　Design Control / Documentation & Change Control - Identifies areas for process improvement.

　　Provides supporting information for change including reasons and justifications.

　　Quality Engineering - Coordinates quality decisions between different quality and engineering groups.

　　Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g., FMEAs).

　　Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Provides compliant solutions to a variety of complex problems.

　　Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.

　　Decisions may have short- and long-term impact.

　　Required Qualifications

　　Apprenticeship or bachelor’s degree in Life Science, Engineering, or closely related discipline, Or and equivalent combination of education and work experience.

　　Minimum 3 years experience working in quality or related field experience; Less experience may be appropriate with advanced degree.

　　Preferred Qualifications

　　Demonstrates understanding of how their function supports the business.

　　Demonstrates technical and business competencies that drive results and continuous improvement.

　　Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11/Annex 11.

　　Project experience in validation testing practices, methodologies, and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.

　　Must have excellent oral and written communication skills.

　　Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

　　Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.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 www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

　　The base pay for this position is $64,000.00 – $128,000.00. 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]