Lead Engineer Quality

Abbott; Alameda (CA); On-site; USD 100,000 - 200,000; Full time

Benefits offered by this job

HIP PPO medical plan

Employer retirement contribution

Tuition reimbursement

FreeU education benefits

Job summary

Abbott in Alameda, CA is seeking a Lead Quality Engineer to own investigations related to product complaints and CAPA-driven actions. You will work cross-functionally to uncover root causes and ensure timely corrective actions in a healthcare environment.

This role requires deep technical product knowledge, strong problem-solving, and the ability to lead a team within the Post-Market Surveillance group across multiple Abbott business units.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

CAPA investigations

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree or higher

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Lead, Quality Engineer

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 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.

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. 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.

What You’ll Work On

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• Quality Assurance and healthcare industry disciplines preferred.
• Minimum 4 years overall quality experience in an FDA/ISO regulated environment preferred.

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. 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.

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.