Document Control

Document Control – Site Queretaro

About Abbott

Abbott, global leading healthcare company, is investing in Mexico. We are building a manufacturing facility in Querétaro.

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.

This facility will offer 1,200 local new jobs and will be the first health manufacturing facility in Querétaro (pioneers for healthcare Hub).

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.

Main Purpose of the Role

This position executes Documentation Control activities which includes:

· Activities regarding documentation and databases systems per applicable Quality Systems procedures (winchill or SAP) desirable.

· Coordinate translation services between English and Spanish for the applicable controlled documentation.

· Effective execution and support on the Quality Records activities in the Documentation Control 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.

Main Responsibilities

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.

· Work with remote facilities as necessary to assist in changes that affect multiple locations.

· Maintain appropriate logs and records, if required.

· Provide assistance to change requestors in updating documents, creating or updating Bills of Materials, parts, routers and submitting change requests, etc.

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. 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.  

· Responsible for maintenance of documentation databases.

· Review all quality records at receipt for accuracy of identification and quantity.

· 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.

Education Level:

· Bachelor’s degree Engineering quality systems or similar.

· Computer skills

· Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint)

· 6 months -1 year

Other Qualifications and Education

· Experience in an FDA or ISO controlled industry.

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

· Knowledge of FDA, GMP, and ISO 13485.

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

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