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.

CAPA Quality 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 Diagnostic 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 CAPA Quality Specialist, you’ll be responsible for assisting in the implementation and maintenance of an effective Quality System for the site.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.

• Independently contribute to Quality System processes which may include training, corrective action, and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.

• Determine quality attributes and requirements. may provide technical assistance.

• Independently utilize quality management techniques to perform investigations and facilitate solutions.

• Responsible for independently completing documentation in a timely manner and in accordance with business standards.

• Supports required activities for monthly metrics and drive decisions in a timely manner

• Ensure work complies with regulatory and compliance standards

• Ability to communicate constructively and utilize technical writing skills for quality records

• Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.

• Manage and coordinate CAPA projects and identify continuous improvement opportunities

• Ability to investigate and utilize DMAIC problem solving tools

• Understand and comply with applicable EHS policies, procedures, and guidelines.

• Works under general supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment; identifies and quantifies technical risks and their consequences relative to the success of part of a project; recommends appropriate action; decisions or recommendations would typically achieve department / project objectives; drives functional performance to ensure that cross-functional standards and expectations are met; may assist in the training of personnel as directed by management; may mentor others.

• Assist with other support duties as assigned.

• Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.

• Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.

• Collaborates with members of the Quality Assurance team working on special projects.

• Participate on permanent and temporary teams which are process or project driven.

• Become familiar and subject matter expert on electronic support systems, TrackWise, TeamCenter, SAP, ADMS, etc.

• Collect analysis and publish quality metrics.

Required Qualifications

• Bachelor’s Degree.

• Direct experience in a Quality or Regulatory Affairs role in a GMP related industry.

Preferred Qualifications

• Minimum 2 years of related experience.

• Demonstrated technical competency and working technical knowledge and application of concepts, practices, and procedures.

• Previous experience in Quality, CAPA, risk management and/or complaints.

• Previous experience in medical device industry.

• 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.