Risk Management Leader, Quality Systems (Medical Devices)

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

Benefits offered by this job

Health benefits

Tuition reimbursement

FreeU education benefit

Competitive retirement plan

Job summary

Abbott in Dallas, TX, is seeking a Risk Manager to serve as the Division SME for developing and implementing quality systems related to Risk Management. The role offers exposure to global regulatory programs and cross-functional teams within the Diagnostics Division.

You will design methods and tools for risk activities, oversee the Quality System element, interpret global requirements, mentor teams, and coordinate inspections with regulators such as FDA, ISO, and AQR.

Qualifications

• Bachelor's degree Life Science or engineering preferred to understand technical issues or equivalent experience.
• 8–10 years experience in product safety risk management in research/engineering, new product development, operations and/or compliant handling.
• Experience with risk management (ISO 14971) required.

Responsibilities

• Develop methods, tools, and procedures to conduct risk management activities.
• Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element.
• Interprets regulations and requirements and implements programs to meet requirements worldwide for Risk Management.
• SME for domestic/international sites and affiliates regarding Risk Management Quality System element.
• Estimates project levels of effort and resource requirements by working with appropriate staff to understand scope of effort.
• Directs project execution by assigning tasks, tracking schedules, identifying risks, and developing contingency plans.
• Resolves project issues by working with team members, project customers, and others as appropriate.
• Interfaces with senior management on significant matters across organizational units.
• Represents during inspections and inquiries from regulators such as FDA; ISO; and AQR as it relates to product Risk Management.
• Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.
• Mentor, coach and train engineering staff to prepare Health Risk Assessments.

Skills

Risk management

Regulatory awareness

Team collaboration

Education

Bachelor's Degree Life Science or engineering

Master's Degree preferred

Job description

Abbott in Dallas, TX, is seeking a Risk Manager to serve as the Division SME for developing and implementing quality systems related to Risk Management. The role offers exposure to global regulatory programs and cross-functional teams within the Diagnostics Division.

You will design methods and tools for risk activities, oversee the Quality System element, interpret global requirements, mentor teams, and coordinate inspections with regulators such as FDA, ISO, and AQR.