Senior Quality & Compliance Engineer

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

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.