Principal Quality Engineer
Alameda, CA - USA
Job Summary
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. Youll 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 bachelors 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 Youll 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)
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 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
Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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 Abbotts Electrophysiology (EP) business were 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 Abbotts Heart Failure (HF) business were developing solutions to diagnose monitor and manage heart failure allowing people to restore their health and get on with their lives.
Diagnostics
Were 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 Abbotts 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 worlds greatest healthcare challenges.
Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to lifes 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
$114000.00 $228000.00In specific locations the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Staff IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more