Sr Eng, Quality

Baxter Healthcare; Tijuana; Presencial; MXN 420.000 - 660.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equal opportunity employer

Reasonable accommodations

Descripción de la vacante

Baxter Healthcare seeks a Sr Eng, Quality to establish and maintain systems, ensuring compliance with QSR 820, ISO-13485 and regulatory requirements. You will lead quality resources and sustainment projects under supervision.

You will drive NCR/CAPA activities, audits, data analysis, and cross-functional collaboration to ensure product quality and timely project milestones in a manufacturing setting in Mexico.

Formación

• 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 Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC, and EUMDR.

Responsabilidades

• 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, Gemba’s, 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.

Conocimientos

Quality control

Regulatory compliance

Root cause analysis

Quality audits

Lean principles

Statistical methods

Educación

B.S Degree in Engineering

Herramientas

ISO13485

Descripción del empleo

This is whereyour 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, Gemba’s, 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.

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.

Emilio Flores #2471-A|Col. Cañon del Padre|22203 Tijuana, BCN|Mexico