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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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. 

• 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 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.  

• 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.  

The Opportunity  

This position works out of our Pleasanton, CA location in the Heart Failure division. 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.  

As the Associate CAPA Engineer you will generate exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine manufacturing issues. Independently investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions. Utilize device design history files, specifications, test methods, factory data, field data, or quality policies as necessary to support decisions. Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities. Work with Quality, Technical Operations, Manufacturing, Engineering, or purchasing as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations. Concurrently manage multiple CAPA projects and tasks, ensuring timely completion. Track and trend CAPA related information, as appropriate, to meet compliance requirements. Be key contributor of CAPA team in identifying, developing, and implementing process or product improvements. Support the creation, implementation and modification of product and process related documents including Operating Procedures and other related documents.

What You’ll Work On 

• Ensure that all CAPA documents are written in compliance to Division policy and site procedures.
• Document and investigate route and non-routine manufacturing issues independently or in collaborate with subject matter experts to develop robust CAPA solutions.
• Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
• Be key contributor to identifying and/or implementing CAPA process improvements.
• Accountable for strict compliance to cGMP as it relates to CAPA documentation accuracy, decision accuracy, process compliance, process efficiency, and timeliness.

Required Qualifications 

• Bachelors Degree or an equivalent combination of education and work experience
• CAPA work experience in manufacturing plant environment.  
• Minimum 2 years experience in regulated, manufacturing environment.

Apply Now 

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. 

     

The base pay for this position is

$72,100.00 – $114,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

HF Heart Failure

        

LOCATION:

United States > Pleasanton : 6101 Stoneridge Dr

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

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.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf