Job Description - ABOJP00024837 - Risk Management Project Manager III in Irving
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ABOJP00024837 - Risk Management Project Manager III

Ref: US_EN_6_971662_1457405

Posted on 25 July 2022

Modis is searching for a Project Risk Manager III for a position with an American multinational medical devices and health care company. This role is located is Irving, TX and is a great opportunity offering a work life balance with competitive pay, and benefits. The Project Risk Management III role will be responsible for collaboration with other departments to develop, implement, and maintain a risk management process in the Quality System.

DUTIES

  • 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.
  • Other duties as assigned, according to the changing needs of the business.
  • Create schedules, identify and communicate risks to stakeholders, define risk mitigation strategies, and facilitate appropriate engineering solutions.
  • Develop system requirements to streamline and simplify tools used to manage and enhance operational productivity, accuracy, and effectiveness for customers.
  • Evaluate effectiveness of current or future systems.
  • Collaborate with other departments to integrate with business systems and processes.
  • Maintain metrics, reports, and process documentation to monitor and analyze delivery performance and key controls.
  • Manage cross-functional teams and/or third party-vendors for implementation of project/program requirements.
  • SKILLS

  • 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 in working 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;
  • Equal Opportunity Employer/Veterans/Disabled

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    The Company will consider qualified applicants with arrest and conviction records

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