Commercial Quality Specialist

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. JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve peoples health. Were always looking towards the future, anticipating changes in medical science and technology. Our diagnostic solutions are utilized in hospitals, laboratories, and clinics worldwide. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions, ranging from heart attacks to blood disorders, infectious diseases, and cancers. 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. Youll also have access to: Career development with an international company where you can grow the career you dream of. 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. 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 bachelors 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Abbott Rapid Diagnostics (ARDx) is part of Abbotts Diagnostics family of businesses, delivering industry-leading technologies and expert teams to support diagnostic testing that informs treatment and disease management. We have an opportunity for the role of Commercial Quality Specialist based in the Lake Forest, IL office. This role supports both the Global Commercial Quality Management System (QMS) and U.S. Commercial Quality operations. It ensures compliance with applicable quality, regulatory, and GxP requirements while supporting the implementation and execution of Abbotts Global Quality and Regulatory Framework, including Business Unit policies and procedures. What Youll Work On Global QMS Support Support the Global Quality Systems for the ID Commercial Quality team under the direction of the Global QMS Lead. Support the development, implementation, maintenance, and effectiveness of the Quality Management System (QMS) in compliance with ISO, FDA, GxP, and Abbott requirements. Enable compliance across Global Commercial Quality teams with applicable policies, processes, procedures, and quality metrics. Manage crossfunctional quality initiatives, QMS reviews, issue escalation, CAPA trending, and continuous improvement activities. Commercial Quality Operations (U.S.) Support implementation of Quality and Regulatory requirements, driving compliance with the Abbott Global Quality/Regulatory Framework and Business Unit policies. Maintain and monitor the commercial QMS to ensure ongoing suitability, adequacy, and effectiveness. Support quality decisionmaking, escalations, audits, inspections, CAPAs, complaints, and postmarket surveillance activities. Coordinate quality metrics, Quality Management Reviews, and timely resolution of product and quality issues. Required Qualifications Bachelor's degree in Pharmacy, Science, Engineering, or a related discipline. Minimum 3 years of experience in a regulated Medical Device, Pharma, or IVD environment. Preferred Qualifications Demonstrated leadership skills in achieving company goals and objectives. Experience working in a highly matrixed, global, and crossdivisional enterprise environment. Quality systems management experience, preferably within the Medical Device or IVD industry. Project management experience, including managing or supporting QMS development initiatives within the healthcare industry. * 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 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 $61,300.00 $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ID Infectious Disease LOCATION: United States > Lake Forest : J55 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter