Document Control Associate I

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.

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 me

dical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

• →Assure effective change request administration.

• →Ensure that all change requests comply with procedure requirements.

• →Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation.

• →Coordinate implementation of change requests with all affected areas/facilities.

• →Prioritize and schedule completion of approved change requests.

• →Maintain accurate configuration control.

• →Control part numbers and revision level assignments.

• →Maintain product configurations by ensuring accuracy of Bills of Materials.

• →Control Device Master Records.

• →Maintain item master accuracy by updating additions, deletions, and other changes as required.

• →Provide technical support to facility projects.

• →Assure effective documentation control administration

• →Technical written translation services between English and Spanish for the applicable controlled documentation and enforcing adherence to written documentation policies and procedures.

• →Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met.

• →Distribute notifications and updated documents to applicable areas, as required.

• →Proofread documents for accuracy and adherence to policies, as necessary.Support translation activities of controlled documents, as required.

• →Provide technical support to facility projects

• →Support project teams to ensure change requests are implemented to meet deadlines.

• →Support facility projects to ensure accurate product configuration and documentation of new/existing products.

• →Provide technical support to departmental activities to troubleshoot documentation and ERP system problems and provide solutions.

• →Miscellaneous:

• →Support all divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• →Provide training as requested to other documentation personnel. P

• →rovide training as requested for Windchill CRO users as required.

• →Provide support during internal and external audits

• →Other duties as assign.

• Bachelor’s Degree in Engineering, Business Administration, English-Spanish Translator or other related field.

• 0-1 years of working experience on similar roles.

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

• Intermediate command of English language.

• undefined

• At least 1 year of experience in an FDA or ISO controlled industry is preferred.

• Knowledge of ERP/PDM databases (i.e. SAP, Mfg-Pro, Windchill) preferred.

• Knowledge of FDA, GMP, and ISO 13485 is preferred.

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