Lead Engineer Quality
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Benefits offered by this job
Job summary
Abbott in Alameda, CA seeks a Lead Quality Engineer to own complex investigations in the CAPA system within Diabetes Care. You will drive root-cause analysis, establish ADC investigation methods, and work cross-functionally with Operations, R&D, QA, and Customer Service to implement effective conclusions.
The role emphasizes leadership, documentation excellence, and ongoing process improvements within Post-Market Surveillance, contributing to safer, higher-quality medical devices.
Qualifications
- Bachelor’s degree or equivalent with 8+ years QA experience; 12 years considered.
- Strong problem-solving and critical-thinking, especially in CAPA.
- Experience cross-functionally in quality investigations within a QMS.
- Healthcare/FDA/ISO regulated environment preferred.
Responsibilities
- Isolate root causes and implement effective solutions using analytical and investigative techniques for product issues.
- Establish ADC investigation and reporting methodology for elevated complaints and field issues.
- Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
- Represent Post-Market Surveillance and Product Quality Engineering in escalations at cross-functional level.
- Review and approve project and quality system documentation.
- Develop team members and implement process improvements within Post-Market Surveillance.
Skills
Education
Tools
Job description
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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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, and FreeU 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.
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. We’re 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.
- Isolate root causes and implement effective solutions by means of sophisticated analysis and investigative techniques for product issues.
- Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
- Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
- Represent Post-Market Surveillance 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 members of the team and implements process improvements within the Post-Market Surveillance team.
- Bachelor’s 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.
- Quality Assurance and healthcare industry disciplines preferred.
- Minimum 4 years overall quality experience in an FDA/ISO regulated environment preferred.
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. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
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.
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.
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.
Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.
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.
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.
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.
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.
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.
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.
$100,000.00 – $200,000.00
In specific locations, the pay range may vary from the range posted.
Operations Quality
ADC Diabetes Care
United States > Alameda : 1360-1380 South Loop Road
Standard
Not specified
Not Applicable
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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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