Eng Quality

Baxter International Inc.; Tijuana; On-site; MXN 420,000 - 660,000; Full time

Job summary

Baxter International Inc. in Mexico is seeking a Quality System Engineer to support the internal audit process, document and record control, and the CAPA system within the Quality organization. The role requires a B.S.

in engineering, 1–3 years of quality systems experience, and knowledge of ISO 13485 and FDA QSR 820, plus proficiency with Microsoft Office and tools like SAP, TrackWise and Power BI. You will coordinate audits, support regulatory compliance, train personnel, and help maintain the

Qualifications

• Bachelor's degree in engineering required.
• 1–3 years of experience in quality or quality system engineering.
• Knowledge of ISO 13485 and FDA QSR 820.
• Proficient in Microsoft Office.
• Familiar with SAP, Trackwise and Power BI.
• Regulatory knowledge for medical devices incl. FDA 21 CFR 820 and EU MDR.

Responsibilities

• Ensure compliance with QSR 820, ISO-13485 and applicable laws.
• Prepare KPI presentations at corporate level.
• Administer CAPA system (TW8) and user accounts.
• Administer Audit system (TW9) and supervise accounts.
• Coordinate product audits.
• Address site regulatory requirements.
• Support Quality Culture program activities.
• Provide training on Quality systems and GMP.
• Review documentation for the Quality Management Framework.
• Review engineering change releases and documentation.
• Maintain document matrix and record storage.

Skills

Quality System Engineering

Microsoft Office

Regulatory knowledge

Documentation control

Audit coordination

Education

B.S Degree in Engineering

Tools

SAP

TrackWise

Power BI

Job description

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your role at Baxter:

You, as Eng, Quality, will be responsible for Supports Quality System compliance by handling the Internal Audit process, Document and Record Control and CAPA system.

What you will be doing:

• Ensure compliance with QSR part 820, ISO-13485 and other applicable laws.
• Ensure Quality Key Performance Indicators at plant level and prepare presentations at corporate level.
• Ensures the administration of CAPA's administration system (TW8) in account generation, providing education on how to operate it, along with leading all aspects of the release of user accounts.
• Administrate Audit system (TW9) in generating accounts, deliver instruction on its use, as well as supervising the user accounts releasing.
• Coordinate product audits.
• Coordinate and respond to site regulatory matters or requirements.
• Responsible Quality Culture Program for the site, that consist: Quality Week, Quality Messages, Training in quality culture and supervising the progress of the Quality Hero program.
• Provide training in the Quality system, such as: Good manufacturing practices at an indirect and direct personnel.
• Coordination responsible for:
• Periodic Review of Documentation for the Quality Management Framework.
• Review of the accurate release of engineering changes through the implementation plan.
• Develop and follow up to changes related to Quality System Documentation.
• Send weekly notifications of the releasing of revisions in quality system records
• Responsible for Records Storage.
• Responsible for the coordination for the controlled copies distribution.
• Document Matrix Maintenance.

What will you bring?

• B.S Degree in Engineering required
• 1-3 years of experience as quality or Quality System engineer.
• Knowledge in ISO 13485 and the FDA's quality system regulations outlined in Title 21, Part 820.
• Use of Microsoft Office.
• Knowledge desirable on systems such as: SAP, Trackwise, Power BI.
• Desired knowledge in regulatory requirements and standards for medical devices includes FDA regulations found in Title 21 CFR, Part 820. It also covers the European Medical Device Directive 93/42/EEC and EUMDR.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.