Quality Systems & Compliance Engineer I

     

JOB DESCRIPTION:

Quality Systems & Compliance Engineer I (Shift Adm)

 

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 I, you will Supports 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

 

• Creates and/or maintains employee learning maps ensuring they are up to date with the current version on applicable QMS documents.

• Manages 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.

• Supports internal compliance audits at the Costa Rica facility.

• Supports the coordination of the external audits/inspections 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.

• 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.

• undefined

Required Qualifications

• Bachelor’s Degree in Engineering, Business Administration or related fields 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 of experience in related positions.

• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).

• Knowledgable of Quality Management Systems (QSRs, ISO 13485 or ISO 9001)

• Intermediate command of English language (required).

 

Shift Admin (Monday to Friday 8:00 pm to 5:00 pm)

Works 100% on site

Preferred Qualifications

• Proficient in Power BI (most preferred).

• Prior medical device industry experience.

• ASQ CQE / Six Sigma or similar certification.

• Participation or leading multi-departmental project teams.

• Experience in supervision role.

• Master's Degree on position related field.

 

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:

EP Electrophysiology

        

LOCATION:

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

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Cr09Sal (Costa Rica)

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)