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. **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** We have an opportunity for the role of **Senior Quality Professional - Validation** is within our **Transfusion Medicine division** based out of Irving, TX. Abbott Transfusion Medicine is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, and clinics. Our products offer automation, convenience, cost-effectiveness, and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company’s commitment to improving patient care and lowering overall costs. As a Senior Quality Professional- Validation, you’ll conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. Supports validation activities, including facilities, utilities, and equipment (FUE), processes, and test methods across multiple Transfusion Medicine (TM) Division locations collaborating with other engineering disciplines, departments and contractors. **What You’ll Work On** + Defines project goals and milestones. Responsible for timely project completion. + Receives general direction and exercises considerable discretion to own work detail. + Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. + May lead validation projects with cross-functional or broader scope. Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors. + Communicates confidently and effectively with management, peers, and key stakeholders. + Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. + Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues. + Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Accepts ownership and responsibility for decisions. + Effectively engages team members and provides guidance to various functions, other professionals, and technicians. + Assists team members in meeting their goals by providing coaching and mentoring as needed.Analyzes data, procedures, and requirements with consideration given to financial and business outcomes. + Identifies areas for process improvement and provides supporting information for change, including reasons and justifications. + Reviews documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects. **Education and experience you’ll bring:** **Required Qualifications** + Bachelor’s degree in Life Science; Engineering; or closely related discipline; OR an equivalent combination of education and work experience. + Minimum 5 years in quality or related field experience; Less experience may be appropriate with advanced degree. **Preferred Qualifications** + Preferred experience in the medical device or pharmaceutical industry. + Has a history of completing successful projects and driving positive compliance outcomes. + Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11/Annex 11. + Knowledgeable of ALCOA+ data integrity principles. + Good understanding of Cybersecurity principles as applied to computerized systems. + Project experience in validation practices, methodologies and techniques, particularly in validation of computerized equipment, processes, and test methods used to support medical device manufacturing or experience leading validation teams is a plus. + Must have excellent oral and written communication skills. + Experience communication with management, peers, and stakeholders. + Strong analytical and problem solving skills. + Experience using analytical and data visualization tools, such as Microsoft Power BI. * 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 $75,300.00 – $150,700.00. 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 corpjat@abbott.com