Abbott Project Manager - Quality Risk Management Process in Abbott Park, 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.
*Internal Job Title: Project Manager - Risk Management
Abbott Diagnostics has an opening for Project Manager - Product Safety Risk Management. This individual will be the subject matter expert providing product safety risk management guidance and direction to all areas associated with the design and manufacture of medical diagnostic products.
Implementing and maintaining the effectiveness of the quality system.
Develop, implement, and maintain a risk management process in the Quality System that conforms with ISO 14971 across product realization by providing strategic and tactical direction.
Maintain a sound, consistent, and sustainable approach to risk management.
Manage health and safety risk by identifying and communicating product safety risks at each phase of the product lifecycle.
Create and maintain risk management records compliant with international standard ISO 14971 and Divisional procedures.
Define best practices to aid in the implementation of risk management requirements.
Provide guidance to product teams regarding risk identification, assessment; control, and communication
Project Planning: Participates in project planning, updates and process improvements.
Documentation: Appropriately documents risk management files that may include but limited to Risk Analysis, FMEAs and Reports.
Travel %: None
- Across functional areas/programs within division. Contributes to project planning. Responsible for projects risk management lifecycle.
Bachelor’s Degree in Life science or engineering degree preferred to understand and interpret technical issues. Master's preferred.
Minimum of 3 years’ experience in product safety risk management in research/engineering, new product development, operations, and/or complaint handling.
Experience with risk management (ISO 14971) required.
Experience should include work with regulations and standards affecting In Vitro Diagnostic product design, development and manufacture.
Knowledge of diagnostics instruments, reagent products, development, manufacture, and customer use is desirable.
Preferred/Ideal Experience, etc.:
- Above work experience from IVD or pharmaceutical industry.
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 firstname.lastname@example.org