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 Structural Heart Division, located in Zona Franca Coyol, Alajuela. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Quality Systems & Compliance Engineer II, you’ll have the chance to be responsible for integrating and maintaining quality management systems and providing quality system support for the Costa Rica site. Under general supervision, administers regulatory compliance of the Learning Management System (LMS).  

What You’ll Do

• Set up training audiences, certification trainings, courses, versional documents, and track in-class, online, onsite and offsite training within the LMS software.
• Develop, run, and distribute reports as scheduled or upon request for management and/or internal or external audit purposes.
• Maintains and enhances Quality systems by identifying, isolating, and resolving problems with existing processes, using customer feedback and automated systems.
• Maintains awareness of standards that regulate our industry. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Responsible for implementing and maintaining the effectiveness of the quality system and providing support to Quality and Compliance Management to ensure Plant regulatory compliance.
• Participates in, and supports readiness activities successful completion of internal and regulatory Audits and assessments.
• Provide support to the Quality Systems team in the maintenance of the Quality Management System elements.
• Provides input to Management Review on external audit/inspection results.
• Participates in the coordination of quality related activities.
• Communicates the status of overall compliance to management.

Administrative Shift

Required Qualifications

• B.S. in Engineering, Business Administration, Human Resources or Science.
• Bachelor’s Degree with demonstrated experience in Quality, Engineering or work within structured processes.
• 1-2 years work experience and Quality Management Systems knowledge.
• Intermediate command of English.

Preferred Qualifications

• Quality Auditor training for ISO 13485 or 9001.
• 1-2 years of experience participating on ISO and/or FDA audits is a plus.
• Six Sigma certification preferred.
• Experience in managing readiness activities for external audits.
• Familiarity with the exception (CAPA) process and its administration.
• Understanding of quality root cause analysis and corrective action methodologies.
• Background in conducting assessments (audits) on the production floor and its supporting areas.
• Oversight of gap evaluations requested from other sites to identify deficiencies in the Quality System and implement necessary improvements.
• Expertise in the Management Review process of the Quality System, including its performance indicators.
• At least 2 years of background in the medical device industry (Quality or Manufacturing).
• Proficiency in English and Spanish | C1 (spoken and written).
• Strong interpersonal skills, with the ability to engage across all organizational levels.

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.

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