Senior Analyst Quality Assurance

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 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• An excellent retirement savings plan with 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 around the world and named one of the most admired companies in the world by Fortune.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels

As a Senior Analyst Quality Assurance, you will interpret applicable internal and external requirements and translate to produce documents such as procedures and partnership agreements that are in line with the Quality System. Define process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards. This is an onsite opportunity based in Alameda, CA.

What You'll Do

• Provide support in external inspections/audits.
• Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division's quality systems
• Collect and analyze quality data as needed for monthly metrics and data driven recommendations based on trends.
• Initiate and maintain design and on-market change notifications between the division and External Partners.
• Ensure internal activities and external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485
• Ensure external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485.
• Identify areas of potential noncompliance within Abbott or with external partners.
• Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in business processes internally or with external partners.
• Assist in the evaluation, development, and maintenance of Quality Agreements.
• Participate cross functionally and across business units to standardize Abbott business quality system policies and procedures.
• Lead and implement process improvement initiatives.
• Assist in the development, review, approval, and change control of Quality System and/or external partnership related documents.
• Perform other duties as assigned by Management.

Experience You'll Bring

Required

• Bachelors Degree
• Preferred Healthcare industry and experience in quality function.
• Utilize understanding of how their function supports the business and of technical/business competencies to drive continuous improvement results.
• Minimum 4 years in Quality or related field.
• Demonstrates proven track record utilizing core & technical competencies.

Preferred

• Quality Assurance experience in Medical Device manufacturing industries
• Working Knowledge of applicable regulations and standards such as, FDA QSR and ISO13485

• Qualified in Injection Moulding Process development SIM study to Master Moulder level would be an advantage

Apply Now

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free cov erage applies in the next calendar year.

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 and @AbbottGlobal.

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 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 through the design and provision of device and management solutions for the treatment of 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.

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections 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 are 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.

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®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

The salary for this role is between $92,800 – $185,600