.About AbbottAbbott 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 AbbottAt 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 Will Have Access To:Career development with an international company where you can grow the career you dream of.A company 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.What You Will Do:Responsibility for compliance with Abbott Commercial Quality System (QS) and local laws and regulations.Ensuring Quality System effectiveness through implementation and maintenance of respective procedures and processes.Assurance that all relevant requirements are met prior to distributing product in the countries/region incl. product labelling with country regulations.Supervision and control of compliance with quality procedures, incl. implementation, training, and documentation.Providing expert quality advice and supports commercial/ business processes regarding quality aspects, incl. e.G. launches and/or other commercialization projects/processes.Planning and conducting internal and external audits to verify the effectiveness of the management system.Effectively executes key quality processes e.G., Management Reviews, Supplier/ Distributor/ Warehouse Control, CAPA, Ad/Promo, Quality Hold, Document Control and Record Keeping according to established and/or newly developed procedures (e.G. OneAbbott) and supports further developments.Performs evaluation, re-evaluation and monitoring of suppliers/distributors/warehouses. Evaluate Third-Party Warehouses and Distributors with respective on-site audits (as appropriate).Support of medical event reporting and field actions in close cooperation with PQA, Customer Service, Regulatory Affairs and Vigilance/MEG.Supports local complaint handling/product replacement process and related aspects e.G., with relevant partners/functional ADC units like PQA and represent respectively within the Affiliate Management Team.Initiates, supports, and participates in Quality System improvements and implementation projects.Takes ownership for a QS process and supports the QS Champions Program (e.G., MIMS/ADC Subject Matter Expert/Champion).Travel: Approximately 10-25%.Requirements:Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).Preferably 3-4 years of experience in the Medical Device Industry in the area Quality/Regulatory Affairs or equivalent experience/knowledge of regulatory requirements and applicable quality standards.Solid technical understanding/scientific knowledge of products
