Document Control Associate 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  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 Document Control Associate I, you will execute Documentation Control activities which includes:

• Activities regarding Windchill and SAP systems per applicable Quality Systems procedures.

• Translation services between English and Spanish for the applicable controlled documentation.
• Effective execution and support on the Quality Records activities in the Documentation Control area, via the receiving, processing, scanning, review, and archiving of quality records.
• Guiding site and BU Change Control system users and Documentation Clerks.
• Resolving issues related to Change Control system and Quality Records management.
• This function will work with site projects providing technical support as required.

What You’ll Do

• 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.
  • Provide training as requested for Windchill CRO users as required.
  • Provide support during internal and external audits
  • Other duties as assign.

Required Qualifications

• Bachelor’s Degree in Engineering, Business Administration, English Spanish Translator or another 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.

Preferred Qualifications

• 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.

SHIFT B (Monday to Friday 3:30 pm to 10:00 pm and Saturday 8:00 am to 3:30 pm).

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.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:Quality Assurance

     

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:Not specified

     

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)