Quality Systems Section Lead - Queretaro Site

Abbott; Valle de Chalco Solidaridad, Santiago de Querétaro; Presencial; USD 60,000 - 100,000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Quality Systems Section Lead to oversee the Quality Management System at a new manufacturing facility. This role is pivotal in ensuring compliance with international quality regulations and enhancing product performance. You will lead a dedicated team, drive continuous improvements, and represent Quality Systems in cross-functional projects. This is a unique opportunity to contribute to a pioneering healthcare hub while enjoying career development within a globally recognized organization committed to diversity and excellence. Join a team where your expertise will make a significant impact on health technology advancements.

Servicios

Career development opportunities

Diversity and inclusion initiatives

Recognition as a great workplace

Flexible work environment

Formación

• 7+ years in Quality roles within manufacturing environments.
• Experience with FDA Class II or Class III medical devices.

Responsabilidades

• Develop and maintain Quality Management System programs.
• Lead cross-functional teams for quality initiatives.

Conocimientos

Quality Management Systems

Regulatory Compliance

Risk Mitigation

Team Leadership

CAPA Process Management

Educación

Bachelor's degree in Engineering

Bachelor's degree in Science

Herramientas

Quality Data Metrics

CAPA System

Descripción del empleo

JOB DESCRIPTION:

Quality Systems Section Lead – Querétaro 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.

MAIN PURPOSE OF ROLE

This position is responsible for developing, establishing and maintaining Quality Management System programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and capability to demonstrate conformance to established standards and agency regulations.
MAIN RESPONSIBILITIES
• Provide overall Quality Systems leadership including: direction of the personnel and activities of the team members.
• Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge.
• Aggressively identify opportunities to apply, continuously improve, and redefine Quality Management System and controls for all the product-related processes in accordance with all applicable quality regulations, US 21 CFR 820 (QSR), ISO 13485, EU MDR, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide influential leadership with International sites to drive proactive quality system improvements.
• Represent Quality Systems as required in support of cross-functional projects.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• In coordination with the divisional training function, oversee, develop and provide training to divisional personnel on Quality Management System topic training.
• Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Provide guidance, leadership and organizational support for Product Development projects.
• Provide management and development of the Quality Systems staff.
• Be an effective member of the cross-functional organization to foster continuous quality compliance, cost, and predictive measures improvements.
• Liaison with Corporate Global Quality organization on QMS initiatives.
• Maintain effective Quality Data Metrics and drive and execute activities to resolve decreases in performance.
• Administers the CAPA System elements, Quality Management Review and Quality Data Review for the site.
• Leads the coordination of the internal and external audits/inspections preparation and participate and or support during internal/external audits/inspections, as required.
QUALIFICATIONS
Bachelor's degree : Engineering, Science or related technical field.
Experience/Background

• Experience in Quality roles
• Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.
• Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
• Solid knowledge and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.
• Experience managing Quality Management Reviews, CAPA process and internal and external audits. At least 4 years
• Ability to travel to support domestic and international manufacturing sites (up to 15%).
• 7+ years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
  • FDA Class II or Class III medical device experience.
  • Lead Auditor/Auditor Certification preferred.

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:

Mexico > Queretaro : Fray Junipero Serra 21260

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable