Project Manager # JN -062021-65613

Title                           : Project Manager

Location                    : Lake Bluff, IL

Duration                   : 12 months contract

Description:

Responsibilities:

• 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.

Qualifications:

• Bachelor’s degree. 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.