Compliance Manager
3 weeks ago
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.
The OpportunityThis position works out of our Lake Bluff, IL location in the Transfusion Medicine Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are critical to patient care requiring blood transfusion and plasma treatments.
Job SummaryAs the Compliance Manager, you will provide expert level guidance and direction of the Quality Systems to a team of Quality specialists responsible for developing, establishing, and maintaining quality systems programs, processes, procedures, training materials, and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations.
Key Responsibilities- Serve as site expert on all divisional product-related processes in accordance with applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
- Implement improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
- Represent Quality Systems as required in support of cross-functional divisional projects.
- Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
- Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
- Bachelor's Degree in Engineering or Sciences minimum, OR equivalent work experience in a related field.
- Various management positions outside of Quality and/or Engineering are also required.
- At least three years of solid management experience is a prerequisite.
- Master's Degree preferred
- 9 years of related work experience in quality functional roles desired with at least 3 years of direct management and supervision of personnel and resources.
Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
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