Associate CAPA Engineer

Associate CapA Engineer

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. Working 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, and a student debt program and education benefit are also available. 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.

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.

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. An equal opportunity employer Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com.