Senior Professional Quality

About the role

This role focuses on leading quality-related activities to ensure compliant, high-quality processes, documents, and products for Abbott Diabetes Care. The position oversees the development, implementation, and continuous improvement of Troubleshooting Guidelines (TSGs), while managing workflows, change requests, and cross-functional projects to meet timelines and regulatory requirements.

Responsibilities

• Carries out tasks related to core job responsibilities with little management oversight.
• Oversees the process for development of Troubleshooting Guidelines (TSG) for Abbott Diabetes Care products.
• Ensures timely and successful implementation.
• Prepares the required items to meet TSG deployment deadlines.
• Performs tasks using and managing electronic workflow systems, applying attention to information details and ensuring data accuracy.
• Manages the TSG change request process including holding scrum meetings and backlog grooming activities to ensure their successful execution.
• Works closely with Program manager/project lead on process transformation projects.
• Identifies and elevates areas for continuous improvement.
• May manage continues improvements activities for the department.
• Represents team on cross-functional teams with other functional leaders.
• Interprets project schedules and escalates project timeline risks to management as needed, following through on project deadlines and/or adjustments.
• May lead goals with cross-functional or broader scope.
• Participates in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, validation.
• Responsible for implementing and maintaining the effectiveness of the Quality System.

Requirements

• BS degree in life sciences or engineering.
• 5+ years experience in Quality or related field.

Preferred Qualifications

• Demonstrates accountability, strong attention to detail and a commitment to accuracy.
• Demonstrated initiative and problem-solving skills.
• Exhibits excellent verbal, written, and interpersonal communication skills when interacting with both internal and external customers and stakeholders.
• Displays solid organizational skills, with the flexibility to quickly realign priorities to meet changing business needs.
• Effective project management skills : Project planning, scheduling, resource allocation, and risk management.
• Adaptability and Flexibility : Agility, openness to change, and resilience.
• Experience in a GMP environment.
• Knowledge of FDA Quality System Requirements for Medical Devices.
• Knowledge of ISO 13485 standard.
• Leadership qualities, persuasion, and team empowerment.