Senior CAPA Specialist

Senior CAPA Specialist  

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.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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 Irving, TX location in the Core Lab Division. 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.

As the Senior CAPA Specialist, you’ll conduct quality-related activities to deliver consistent; high quality documents; services; products and processes in the CAPA group, which adds value to the business. This position will own Nonconformance records, documents Nonconformance outcomes, completes Root Cause Investigations, and documents all aspects of the CAPA process.

What You’ll Work On

• Contributes to defining and timely achievement of overall project goals.

• Provides compliant solutions to a variety of problems of moderate scope and complexity.

• Interacts effectively with employees, managers, and peers.

• May lead a project with a limited scope, but usually a contributor on broader projects.

• Provides guidance to other Professionals and Technicians.

• Quality System Compliance -Maintains awareness of standards that regulate the medical device industry.

• Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.

• Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

• Risk Management - Applies basic Risk Management principles to work.

• Ensures compliant documentation related to area of responsibility.

• Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Provides compliant solutions to a variety of complex problems.

• Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.

• Decisions may have short- and long-term impact.

• Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly.

• Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines.

• Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.

• Applies solid understanding of quality system elements from product inception through launch. While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers.

Required Qualifications

• Bachelors degree in Life Science, Engineering, or closely related discipline; Or an equivalent combination of education and work experience.

• Minimum 5 years experience in quality or related field experience; Less experience may be appropriate with advanced degree.

Preferred Qualifications

• Experience owning and managing CAPA records.

• Experience with utilization of quality tools for Root Cause identification

• Cross-functional team management experience

• Demonstrates technical and business competencies that drive results and continuous improvement.

• Preferred experience in the Healthcare industry.

• Has a history of completing successful projects and driving positive compliance outcomes.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage 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.