Senior Professional Quality

Abbott • Alameda, CA

7d • Onsite

About The Position

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. It also involves active participation in Quality System processes, driving process improvements, and collaborating with stakeholders to ensure operational excellence. This is an onsite position that requires the individual to be in the office Monday-Friday.

Requirements

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

Nice To Haves

• Demonstrates accountability, strong attention to detail and a commitment to accuracy.
• Must demonstrate strong problem solving techniques.
• 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

Responsibilities

• Responsible for carrying out tasks related to core job responsibilities with little management oversight.
• Responsible to oversee the process for development of Troubleshooting Guidelines (TSG) for Abbott Diabetes Care products.
• Ensuring timely and Successful implementation.
• Accountable for preparing the required items to meet TSG deployment deadlines.
• Performing tasks using and managing electronic workflow systems, applying attention to information details and ensuring data accuracy.
• Managing the TSG change request process including holding scrum meetings and backlog grooming activities to ensure their successful execution.
• Working closely with Program manager/project lead on process transformation projects.
• Identify and elevate areas for continuous improvement.
• May manage continues improvements activities for the department.
• Represents team on cross-functional teams with other functional leaders.
• Interpreting project schedules and escalating project timeline risks to management as needed, following through on project deadlines and/or adjustments.
• May lead goals with cross-functional or broader scope.
• Participate 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.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Senior