Quality Technician [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.

Main Purpose of the Role

Provide independent evaluation of materials, components, product, and work process within the Quality System. Provide technical assistance to support efforts ensuring the quality of the product. Assist the Engineering team in validations, testing and troubleshooting process to improve processes and product. Assist Engineering team in developing methods and procedures to control or improve processes. Ensure proper performance of tasks from other peers (no direct line reporting and people management duties are involved).

Responsibilities

• Ensure compliance of Corporate and Divisional Policies and Procedures, as applicable.

• Review material, equipment and systems quality through examination, inspection, measurement or testing of raw materials, components, subassemblies, packaging, labeling and documentation.

• Verify and audit processes (e.g. line verification), to prevent Quality System and Manufacturing impact.

• Review and verify compliance of quality and manufacturing documentation (e.g. batch records, reports of nonconforming material and inspection records).

• Execute quality testing of samples as part of its daily activities with no / little guidance from Quality Engineer.

• Identify and segregate nonconforming material from the production line according to governing documents. Coordinates with Quality Engineer to prepare and handle the material in and out of the designated quarantine area.

• Coordinate proper material segregation and identification when in-process nonconformances are identified.

• Propose and execute product acceptance testing, sampling, inspection, classification, or disposal based on engineering disposition. Ensure that all evidence documentation complies with governing procedures.

• Perform root cause analysis and provide ccorrections, preventive and corrective actions to assigned nonconformances under any quality figure from the Abbott Quality System as requested by Quality Supervisor.

• Assist Engineering team in providing manufacturing support by reviewing and analyzing data to determine manufacturing issues or trends.

• Performs data compilation and analysis to determine processes behaviors, trends, improvement opportunities, validation inputs, etc.

• Resolve and prevent manufacturing issues by assisting the Engineering team in determining root cause and implementing corrective and preventive actions.

• Develop and implement process improvement by assisting Engineering team in researching and validating changes in processes or equipment and test methods to improve yield or reduce cycle time per established procedures.

• Lead process and document changes related to nonconformance actions (corrective, preventive or corrections) or process improvement projects and executing all required activities to implement it as: generated document redlines, write, and submit Change Order requests, form and inform the group involved in the corresponding change, etc.
• Troubleshoot and provide inputs to engineering, qualification and validation studies and reports by collecting, compiling, measuring, organizing, recording and analyzing data according to written procedures.
• Execute validation activities defined by protocols.
• Perform the training process for the new or transferred Quality Technicians.
• Contribute to generate work schedules when required by Quality Supervisor.
• Assist supervisor with delegation daily activities to other associates.
• Ensure appropriate process completion for Internal Customer Signal (ICS): units’ delivery and examination, root cause analysis, document investigation, complete corrections or actions as required. Delegates or coordinates with the functional team all related activities.
• Prepare quality data for Functional Team, cross site meetings and monthly Quality Reports. Assists Quality Engineering by presenting quality updates when required.
• Assist in the writing of Build at Risk (BAR’s) and its approval process.
• Support readiness activities for audits.
• Assist operations on electronic DHR clarification or doubts.
• Final product release before and after sterilization.
• Support manufacturing lines, with clarification of documental doubts and correction of documentation errors.

Education:

• Technical career

• 4 years of Experience as a Quality Technician or areas related to Quality Control.
• Knowledge or technical concepts and/or basic develops technologies or processes. Understanding of product or systems fundamentals in cross functional areas.
• Experience on reading and analyzing numerical and statistical data to prepare and present Quality documentation, analysis and problem solving.
• Knowledge of Quality Systems/Engineering required.
• Statistical knowledge including statistical software such as Minitab, JMP.
• Previous experience in assisting with validations, qualifications, test methods or NCMR.
• Knowledge in blueprint reading and experience with sampling techniques.
• Excellent interpersonal and communication skills.
• Certified Quality Technician (CQT) or Certified Quality Engineer (CQE).
• Intermediate English Level.

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.