Principal Quality Engineer

ASPBP; Alameda, Northern (CA, KY); Hybrid; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement savings plan

Tuition reimbursement

Educational benefits

Job summary

Abbott is seeking a Principal Quality Engineer to drive investigations of complaints and lead CAPA projects. You will develop methods to identify root causes, implement improvements, and ensure global quality standards.

Collaboration across R&D, Operations, and other Quality functions is essential. The role requires strong project management, 5+ years of FDA/ISO quality experience, and a BS in engineering or sciences.

Qualifications

• BS in Math, Science, or Engineering disciplines preferred, or equivalent combination of education and work experience.
• Minimum 5 years of Quality experience in a FDA/ISO regulated environment.

Responsibilities

• Lead investigations for complaints and provide recommendations on product improvements.
• Serve as technical lead on large CAPA investigations and develop test methods to identify root causes.
• Develop and implement investigation process improvements.
• Ensure compliance with regulations and maintain the quality system.

Skills

Quality experience

CAPA investigations

Education

B.S. in Math/Science/Engineering

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.

JOB DESCRIPTION:

Job Description

Principal 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

The Principal Quality Engineer will be the liaison to cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to complaints. The lead is responsible for providing recommendations on product improvements as well as serve as the technical lead on large CAPA investigations where the incumbent will develop test methods to identify root/potential causes of complaints. Must be able to analyze data and assist in interpreting the data. Develop and implement investigation process improvements.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Proactively utilize technical depth to understand complaints and works to improve products/process to better meet customer needs with reduced issues.
• Provides guidance with respect to applicable complaint investigation processes, and ensures compliance with regulations with respect to investigations.
• Sets global standards for specifications and drawings that properly identify and highlight critical quality attributes.
• Capture complex technical requirements in policies, design plans, investigations.
• Translates business strategy into meaningful objectives and day-to-day activities required to accomplish them.
• Anticipates future direction and adjusts current processes accordingly.
• Effectively communicates directional changes and creates support for changes.
• Be the technical lead for complaint investigations, and be liaison to other functions, such as R&D, Operations, and other Quality functions.
• Ensure investigation results are disseminated to the relevant SMEs appropriately.
• Structures studies and integrates cross‑disciplinary and cross‑functional issues to arrive at optimal cause of action, e.g. investigates process to meet increasing regulatory requirements while maintaining manufacturing/system construction efficiency.
• Follows through on project goals; contributes willingly and incorporates the ideas of others; shares resources, knowledge and accountability to benefit the objectives of the business, e.g. participates in team meetings; serves either as functional subject matter expert or independent technical expert in management reviews.
• Strong project management skills and able to multi‑task and set priorities to meet overall business objectives.

Required Qualifications

• BS in Math, Science, or Engineering disciplines preferred, or equivalent combination of education and work experience will be considered
• Minimum 5 years of Quality experience in a FDA/ISO regulated environment.

Preferred Qualifications

• Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)

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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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:

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.