Quality Systems & Compliance Engineer I

JOB DESCRIPTION:

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 Structural Heart Division. In Abbott’s Structural Heart, 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 and Compliance Engineer I, you will support Quality Systems activities to evaluate compliance to the requirements of FDA, ISO, MDD, CDR, Japan, and other regulatory bodies applicable to the Quality Management System. Under general supervision, administers regulatory compliance of the Learning Management System (LMS).

What You’ll Do

• Create and/or maintain employee learning maps ensuring they are up to date with the current version on applicable QMS documents.
• Manage the LMS audience structure to maintain standards among current and future Value Streams and support areas.

• In accordance with area’s managers oversees appropriate training planning, execution and documentation for exempt employees.
• Support internal compliance audits at the Costa Rica facility.
• Support the coordination of the external audits/inspection preparation and support and/or participate during external audits, as required.
• Facilitate follow-up and closure of audit/assessment nonconformances.
• Provide support to the Quality Systems team in the maintenance of the Quality Management System elements.

Required Qualifications

• B.S. in Industrial Engineering, Administration or related field or having successfully covered at least 90% of the curriculum at the University to obtain Engineering or Business Administration degree and is currently studying and 2 years previous experience in quality or training related areas.
• 0-2 years work experience.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Knowledgable of Quality Management Systems (QSRs, ISO 13485 or ISO 9001).
• Intermediate Commands of English / Required
• Shift B: Monday - Friday: 3:30pm - 10:00pm and Saturdays: 8:00am - 3:30pm.

Preferred Qualifications

• Experience on Training Management System is highly desired.
• At least 1 year experience in medical device industry is a plus.
• At least 1 year of experience participating on ISO 13485 or ISO 9001 audits and/or FDA inspections is a plus.
• Quality Auditor Certification for ISO 13485 or 9001 is desired.

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.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations Quality

DIVISION:SH Structural Heart

LOCATION:Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:No

MEDICAL SURVEILLANCE:No

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)