Abbott logo

Lead Engineer Quality

Abbott

Alameda, CAJob$100–200K/yrSeen 4 days agoSeen in employer's feed 4 days ago

Most applications go out cold — see where you stand first. No sign-up to start.

Watch jobs like this.

At a glance

Compensation
$100–200K/yr
Location
Alameda, CA
Work Authorization
Not specified

Olive lists jobs from US employers, including remote roles you can work from the United States.

Job overview

Abbott’s Lead Quality Engineer will own complex investigations into trends and emerging product complaint issues captured in the CAPA system. Based in Alameda, California, the role uses product knowledge and investigative methods to identify root causes and support timely, effective corrective actions. The engineer works across functions, represents Post-Market Surveillance and Product Quality Engineering in escalations, reviews quality documentation, and develops team members while improving processes.

Skills & qualifications

RequiredNice to have

Skills

Problem-SolvingCritical ThinkingCross-Functional InvestigationQuality Management SystemsQuality AssuranceHealthcare IndustryFDA/ISO-Regulated Environments

Qualifications

Bachelor's Degree or 12 Years Experience8 Years Quality Assurance Experience12 Years Relevant Experience4 Years Quality Experience

Benefits

Medical Insurance
401(k) Match
Tuition Assistance

Full 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:

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.

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]

Similar jobs, posted recently

Open roles like this one, listed in the last 30 days.

You've read the whole posting — now see how you match it.