JOB DESCRIPTION:

Quality Leader

• 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 the Role

• Responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process.
  May supervise inspection and test activities of operators.
  Performs function failure testing as well as physical defects.

Main Responsibilities

• Oversees operational implementation of quality assurance strategies and regulations.
• Completes the assessment of potential risks, ensures compliance and gives recommendations to management.
• Supervises team to ensure quality control aspects of the process are met (labouratories studies, clinical research, testing, operations, raw materials, production, finished product or services).
• Facilitates audits and regulatory inspections.
• Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organisation's quality standards.

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 @Abbott News and @Abbott Global.

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 : Avenida FINSA 156, Lote 12

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable