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 will have access to:

Career development with an international company where you can grow the career you dream of.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 Costa Rica – Alajuela 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.

As the Quality Systems & Compliance Engineer III, you will be responsible responsible for integrating and maintaining quality management systems and providing quality system support for the Costa Rica site. This includes but no limited to proactive compliance to all applicable standards, divisional quality system and documentation integration, harmonization and improvement.

What You’ll Do

Provides Quality Management System Body of Knowledge support to the organization.Lead cross functional teams to execute Quality System initiatives.As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations.Supports the coordination of the external audits/inspection preparation and support and/or participate during external audits, as required.Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.Identify opportunities for improvement regarding compliance to applicable industry standards and regulations. (i.e. US FD&C, 21CFR11, 21CFR820; EN ISO 13485; EN ISO 14971; EU MDD 93/42/EEC; Etc.)Supports investigating and resolving system nonconformance’s (defined during internal and/or external audits.Works with the organization during change management process and new product introductions to ensure quality deliverables such as Quality Plans and Risk Management are in place for the products being transferred.Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions.Supports the CAPA System elements for the site.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.Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

Bachelor’s Degree in STEM careers or Administration.3+ years of working experience on similar roles.+1 year of experience in an FDA (QSR), ISO 13485 or ISO 9001 controlled industryProficiency in computer applications (MS Excel, MS Word, MS PowerPoint).2 years in Quality Systems, Compliance positions, or demonstrated equivalent experience in Quality (demonstrated knowledge of Quality Engineering, Training, Documentation, Microbiology, Testing and/or Quality Release).Demonstrated experience in Quality, Engineering or work within structured processesIntermediate command of English language.

Preferred Qualifications

Quality Auditor training for ISO 13485 or 9001.Quality Systems related certifications (Quality Control, CAPA, Risk Management, etc.).1-2 years of experience participating on ISO and/or FDA audits is a plus.

SHIFT ADMIN

Works 100% on site

Apply Now

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.