Quality Systems Engineer - Queretaro Site

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.

The Opportunity

To integrate and maintain quality systems in Querétaro in accordance with all applicable regulations, standards and Abbott/AQ policies/Mexican regulations. This includes but no limited to proactive implementation and maintenance of compliance of the divisional quality system and site-specific procedures and practices, search and appliance of integration initiatives and improvements. This role is intended to work independently on the leadership within Querétaro for all-across application of the system and may have supervision responsibilities of direct reports within quality systems organization.

Main Responsibilities

Provides Quality System Body of Knowledge support to the organization.

Lead cross functional teams to execute Quality System initiatives.

As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)

Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations.

Support and execute internal/external Quality System audits

Ensures compliance to all Quality System Regulations and policies applicable to business units in Querétaro by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements

Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to business units in Querétaro

Supports, executes, and resolves investigations related either to non-conformances or improvement opportunities.

Works with the organization during new product introductions to ensure quality deliverables, write Quality Plans and ensure Risk Management are in place for the products being transferred

Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions

Supports the CAPA System elements for the site

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Might be responsible for specific areas within the quality systems organization, driving for excellent operative execution and personnel management (facilitation, training and development)

Performs other duties and responsibilities as assigned.

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.

Responsible for effective change request administration, proper application of ERP configuration control system, providing technical support to project teams as required, maintenance of documentation databases and enforcing adherence to written documentation policies and procedures

Qualifications

Education Level : Engineering, Business Administration, or Science degree

Experience: 4-6 years’ experience in Quality positions.

Language Proficiency: Advance Commands of English / Required

+2 year of experience in an FDA (QSR), ISO 13485 or ISO 9001 controlled industry.

Demonstrated knowledge of quality systems including but not limited to Training, Documentation, Testing and/or Quality Release

Demonstrated experience in Quality, Engineering or work within structured processes, desirable in Medical Devices

Exposure and application of regulations for Medical Devices (FDA-QSR, ISO13485) or experience in ISO9001.

Knowledge and Application of process improvement such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).

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

Preferred Qualifications:

Quality Auditor training for ISO 13485 Lead Auditor or ISO9001

Certified Quality Engineer or AAMI Quality Systems.

Quality Systems related certifications (Quality Control, CAPA, Risk Management, etc).

Certifications on any of the following (in progress or completed): Quality Management, Operational Excellence, Project Management or similar.

1-2 years of experience participating on ISO and/or FDA audits is a plus

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