Job Description

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

This position works out of our Plymouth, MN location in the EP Division.

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.

What You’ll Work On

This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within sustaining, manufacturing, or system/services support.

• Perform inspection of production operations, including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements.

• Document nonconformances as appropriate and assist in the resolution of nonconformances.

• Monitor and/or perform calibration and maintenance of all test equipment and fixtures.

• Initiate related documentation changes.

• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.

• Collect data, summarize, analyze, perform basic statistical analysis on, and document test results

• Assist with or perform Gage R&R studies.

• Assist with the selection, installation and programming of precision measuring equipment.

• Assist in designing, building, and evaluation of test methods and inspection fixturing, providing improvement recommendations.

• Create and maintain control plans for products and processes.

• Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• High school diploma/GED or an equivalent combination of education and work experience

• Minimum of 5 years of related work experience including:

• Previous experience in assisting with First Article Inspections (FAIs), Gage R&R studies, validations, calibration, test methods, and NCMR dispositioning.

• Knowledge of Quality Systems, FDA regulations, ISO 13485, GMP, and applicable worldwide regulatory requirements.

• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing

• Experience with sampling techniques

• Good communication and computer skills, including data analysis and report writing skills.

Preferred

• Prior medical device experience

• Technical degree

• SAP experience

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.