Lead, Quality Engineer
The Opportunity
This position will be based out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We27re revolutionizing the way people monitor their glucose levels with our new sensing technology.
As the Lead Quality Engineer, you will be responsible for owning complex investigations associated with trends and emerging issues associated with product complaints, captured in the CAPA system. This role requires a strong technical understanding of the product, investigation methods, and can work closely cross-functionally to identify root cause of trends and emerging issues to ensure timely and effective investigations and corresponding corrective actions where applicable.
What You27ll Work On
3 Isolate root causes and implement effective solutions by means of sophisticated analysis and investigative techniques for product issues.
3 Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
3 Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
3 Represent Post-Market Surveillance and Product Quality Engineering in escalations and urgent issues being addressed at a cross-functional or divisional level.
3 Reviews and provides functional approval for project and quality system documentation.
3 Develops members of the team and implements process improvements within the Post-Market Surveillance team.
Required Qualifications
- Bachelor27s degree with a minimum of 8 years of experience in Quality Assurance or a related field required.
- An equivalent combination of education and experience, including a minimum of 12 years of relevant experience, will also be considered.
- Demonstrated initiative and problem-solving skills; critical-thinking skills, preferably in a CAPA environment.
- Experience working cross-functionally in an investigative role in a Quality management system.
Preferred Qualifications
- Quality Assurance and healthcare industry disciplines preferred.
- Minimum 4 years overall quality experience in an FDA/ISO regulated environment preferred.
Apply Now
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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
We27re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We27re 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 Abbott27s Electrophysiology (EP) business, we27re 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 Abbott27s Heart Failure (HF) business, we27re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
Diagnostics
We27re 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 Abbott27s 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 world27s greatest healthcare challenges.
Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life27s 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 6 including Similac, PediaSure, Pedialyte, Ensure, and Glucerna 6 to help them get the nutrients they need to live their healthiest lives.
The base pay for this position is
$100,000.00 6 $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 : 1360-1380 South Loop Road
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)
