Commercial Quality Specialist
About The Position
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. 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. 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. You’ll 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 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Abbott Rapid Diagnostics (ARDx) is part of Abbott’s 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 Abbott’s Global Quality and Regulatory Framework, including Business Unit policies and procedures.
Requirements
- 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.
Nice To Haves
- Demonstrated leadership skills in achieving company goals and objectives.
- Experience working in a highly matrixed, global, and cross‑divisional 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.
Responsibilities
- 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 cross‑functional quality initiatives, QMS reviews, issue escalation, CAPA trending, and continuous improvement activities.
- 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 decision‑making, escalations, audits, inspections, CAPAs, complaints, and post‑market surveillance activities.
- Coordinate quality metrics, Quality Management Reviews, and timely resolution of product and quality issues.
Benefits
- 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 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 the best place to work for diversity, working mothers, female executives, and scientists.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
