JOB DESCRIPTION:

Senior Professional Quality Assurance

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

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Diabetes

We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission: Why We Exist

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

EP

In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life's critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® - to help them get the nutrients they need to live their healthiest lives.

The base pay for this position is
$100,000.00 - $200,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
ADC Diabetes Care

LOCATION:
United States > Alameda : 2801 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)