JOB DESCRIPTION:
Senior Professional Quality Assurance
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for 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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
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.
What You’ll Work On
- 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.
- Responsibilities include working closely with Program manager/project lead on process transformation projects.
- Identify and elevate areas for continuous improvement. And 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.
Required Qualifications
- BS degree in life sciences or engineering
- Must have 5+ years experience in Quality or related field.
Preferred Qualifications
- 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
