As the Manager, Product Quality Engineering, you will be responsible for the group initiating and owning investigations associated with trends and emerging issues associated with product complaints, captured in the CAPA system. The group also establishes processes and programs to ensure new products are capable for post-market surveillance as defined in the ADC Quality System at the time of launch. This role requires a strong technical understanding of the product, investigation methods, and the post market surveillance space to ensure timely and effective investigations and corresponding corrective actions where applicable. This role will be expected to oversee and develop a team of individuals with those same skillsets.
What You’ll Work On
Develop Product Quality Engineering teams to isolate root causes and recommend or implement effective solutions by means of sophisticated analysis, investigative techniques and troubleshooting methods.
Establish effective team oversight of new product development to ensure post-market surveillance capabilities at time of launch.
Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
Work with the complaints group and CAPA team to analyze product issues and then conduct investigations to root cause and identify CAs to resolve.
Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
Represent Complaint Handling and Product Quality Engineering in escalations and urgent issues being addressed at a cross-functional or divisional level.
Reviews and provides functional approval for project and quality system documentation.
Develops and implements
Required Qualifications
Bachelors Degree
6 years of experience both overall and any industry-specific experience needed
Preferred Qualifications
Quality Assurance and healthcare industry disciplines preferred or equivalent combination of education and work experience.
Minimum 4 years Overall quality experience in a FDA/ISO regulated environment.
Substantial demonstrated initiative and problem-solving skills; critical-thinking skills, preferably in a CAPA environment.
Experience in leading & managing people.
Experience working in an investigative role in a Quality management system, in collaborations with Quality Assurance/ with Operations and R&D.
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
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
- $114,000.00 – $228,000.00
- 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
No
MEDICAL SURVEILLANCE
No
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)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
