Global Risk & Quality Manager, Medical Devices

Thornton Tomasetti; Irving (TX); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

HIP PPO medical plan

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Dallas, TX is seeking a Risk Manager for the Core Lab of the Diagnostics Division. You will develop methods for risk management, implement the Quality System element, and ensure worldwide regulatory compliance for risk processes.

You will mentor product development and sustaining engineering teams, lead risk assessments, and interact with regulators during inspections to ensure program success.

Qualifications

• Bachelor's degree in Life Science or Engineering or equivalent experience.
• 8–10 years of product safety risk management experience.
• Experience with ISO 14971 is required.

Responsibilities

• Develop methods and tools for risk management activities.
• Implement and maintain the Risk Management Quality System element.
• Interpret regulations and implement worldwide risk management programs.
• Serve as SME for domestic and international sites on Risk Management.
• Estimate effort and resources with staff to scope work.
• Direct project execution and manage risks and contingency plans.
• Collaborate with senior management on significant matters.
• Support inspections by regulators (FDA, ISO, AQR) related to risk management.
• Mentor engineering teams to create product risk assessments.
• Mentor teams to prepare Health Risk Assessments.

Skills

Risk management

Regulatory compliance

ISO 14971

Medical devices knowledge

Education

Bachelor's Degree Life Science or Engineering

Master's Degree (preferred)

Job description

Abbott in Dallas, TX is seeking a Risk Manager for the Core Lab of the Diagnostics Division. You will develop methods for risk management, implement the Quality System element, and ensure worldwide regulatory compliance for risk processes.

You will mentor product development and sustaining engineering teams, lead risk assessments, and interact with regulators during inspections to ensure program success.