Quality Engineer 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 the Role

This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

Main Responsibilities

•Management and development of Quality Engineers and Technicians.

•Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.

•Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

•Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.

•Define and implement Process Control & Monitoring systems.

•Provide influential peer leadership with international partner site to drive proactive quality improvements.

•Identify Quality Initiatives and lead cross-functional teams to complete them.

•Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.

•Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

•Oversee the Nonconformance and Real-time data management portions of the Quality System.

•Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.

•Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

•Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.

•Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.

•Perform other duties and responsibilities as assigned by senior management.

Qualifications and Education

Bachelor's degree.- STEM (Science, Technology, Engineering (preferred) or Bachelor's degree in Business Administration.

5 to 7 years in Quality or engineering roles

•Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.

•Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC).

•Demonstrated results in nonconformance management and reduction, value improvement, risk reduction, and cost containment.

•Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction       

•FDA Class II or Class III medical device experience, preferred

•Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CRE/CQM) preferred.

•Ability to travel to support domestic and international manufacturing sites (up to 15%).

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.