Sr Eng, Quality

Zvh; Tijuana; Presencial; MXN 400.000 - 680.000; Jornada completa

Descripción de la vacante

Baxter in Mexico is seeking a Senior Engineer, Quality, to establish and maintain systems through quality control standards for the designated area, coordinating scheduling and control of quality resources in line with raw material, product, packaging and regulatory specs.

You will lead regulatory compliance, support quality sustainment projects, perform audits, drive CAPA, and collaborate with management to ensure data-driven improvements and timely project delivery.

Formación

• B.S. Degree in Engineering or equivalent experience.
• Two to three years in similar positions.
• Training - Knowledge of risk management ISO13485.
• Formal education or training in quality control techniques, audits, statistics and lean principles.
• Knowledge of regulatory requirements for medical devices (FDA 21 CFR Part 820, EU 93/42/EEC, and EUMDR).

Responsabilidades

• Ensure compliance with QSR part 820, ISO-13485 and other applicable laws.
• Report on metrics to supervise quality performance.
• Lead or participate in NCR, SNCR, CAPA activities following procedures.
• Assist with validation activities (IQs, TMVs, OQs, PQs) for designated areas.
• Support creation and improvement of work instructions and quality plans.
• Conduct internal audits and involved quality system activities.
• Analyze data from field and investigations to resolve issues.

Conocimientos

Quality control

Risk management

Audits

Statistical tools

Design of experiments

Lean principles

Regulatory knowledge

Educación

B.S Degree in Engineering

ISO13485 training

Descripción del empleo

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, Sr Eng, Quality, will be responsible for establishing and maintains systems through quality control standards and procedures for the designated area. Coordinates the scheduling and control of quality resources, and compliance requirements according to raw material, product, packaging and regulatory agency specifications. Leads ongoing regulatory compliance for their area, including quality systems. Supports quality resources and functions related to sustainment projects under the direction of the supervisor.

What you will be doing:

• Ensure compliance with QSR part 820, ISO-13485 and other applicable laws.
• Ensures and reports on metrics to supervise quality performance.
• Ensure that the non-conforming material process is carried out following established procedures and adhering to driven metrics.
• Support with the creation, maintenance and where applicable improvement of work instructions.
• Support with validation activities, IQs, TMVs, OQs, PQs, for designated areas.
• May lead or participate in NCR, SNCR, CAPA activities adhering to established procedures while ensuring compliance with quality objectives.
• Assist management and departmental staff in the implementation of statistical methods for quality assurance to improve operational efficiency and effectiveness.
• Responsible for the analysis of data acquired from the field to investigate and resolve issues identified through Post Market Surveillance Report.
• Participates in project transfer, through the identification and correction of gaps identified in the manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlines.
• Participates in Value Stream projects (quality improvements, cost savings, efficiency gains).
• Ensure that all inspection and test specifications are accurately performed and detailed.
• Conduct a root cause analysis to prevent recurrence.
• Supervise and coordinate the function of the Quality Technicians and Quality Intern.
• Conducts routinely internal audits, Gembas, LTTs pertaining to the quality system in compliance with procedures.
• Reports audit results for management.
• Guarantees alignment with assigned critical metrics and notifies management of any possible impact.
• Supports analysis, investigation and field actions.
• Builds consignees list and contacts clients to acquire required information.
• Composes, monitors and ensures consistency with quality plans.

What will you bring?

• B.S Degree in Engineering or equivalent experience required.
• Two to Three years in similar positions.
• Training - Knowledge of risk management ISO13485.
• Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc.
• Desired knowledge in regulatory requirements for medical devices and standards, including FDA medical device rules outlined in Title 21 CFR Part 820, 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, let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.

To learn how you can protect yourself, review our Recruitment Fraud Notice.

Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.