Job description

Role: Risk Management Project Manager II

Location: Remote

Duration: 12+ Month Contract

Years Experience: 5-7 yrs

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 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;

Education:

Bachelor’s degree. Life science or engineering degree preferred; Master's acceptable;

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 life cycle.
• 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."

Job Types: Full-time, Contract

Pay: $60.00 - $61.00 per hour

Experience level:

• 5 years
• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• product safety risk management: 5 years (Required)
• research/engineering: 7 years (Required)
• new product development: 7 years (Required)
• ISO 14971: 5 years (Required)

Work Location: Remote

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