Abbott Quality Systems Manager - Transfusion in Lake Forest, Illinois
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 103,000 colleagues serve people in more than 160 countries.
Primary Job Function
Division Subject Matter Expert (SME) for quality systems and/or quality subsystems and/or key process(es). Incumbent may be a Key Process Owner for a key process(es) or provides managerial oversight; examples include but not limited to: Learning and Development; CAPA; Advisory Notices and Recalls. Directs multi-site; Division-wide activities to accomplish quality system objectives and goals. The incumbent is the Subject Matter Expert and is the primary representative during internal and external inspections such as FDA; ISO; and AQR.
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
Functions as the SME for a division quality system; quality subsystem and/or key process.
Identifies and recruits staffing resources to support Divisional scope; multi-site quality system projects.
Manages Division-level; professional staff to achieve Division goals and strategic initiatives.
Interprets regulations and requirements and implements programs and procedures to meet requirements worldwide.
Primary Division contact for domestic/international sites and affiliates regarding quality systems; and/or quality subsystems and/or key processes.
The above statements are intended to describe the general nature and level of work being performed; other duties may be performed as assigned.
Position Accountability / Scope
The incumbent will report to the Director of ADD Global Quality Systems and will be a direct staff member. It is expected that the individual will interact frequently with Division Management with executive responsibility; and therefore requires a high level of competence; confidence and credibility. Strategic and tactical decisions for the Division will be made based upon the information that the individual gathers; provides and/or presents in a management setting.
Bachelor’s degree; preferably in a science; technical and/or engineering discipline.
Minimum Experience / Training Re quired
Minimum of 8 years’ experience in Medical device industry or other FDA regulated industry experience.
Minimum of 2 years Abbott experience preferred.
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@example.com
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