Sr, Engineer Quality

Baxter International Inc.; Tijuana; Presencial; USD 30,000 - 60,000; Jornada completa

Descripción de la vacante

An established industry player in healthcare is seeking a Quality Assurance Specialist to ensure compliance with regulatory standards and improve quality systems. In this pivotal role, you will manage quality resources, support sustainment projects, and engage in continuous improvement initiatives. Your expertise will help drive efficiency and effectiveness, making a significant impact on patient outcomes. Join a mission-driven team where your contributions will be valued and recognized, and where you can thrive in a supportive and innovative environment.

Formación

• 3 to 5 years of quality experience in a relevant field.
• Training in risk management and quality systems.

Responsabilidades

• Ensure compliance with QSR regulations and monitor quality performance metrics.
• Manage non-conforming material processes and support validation activities.

Conocimientos

Quality Assurance

Regulatory Compliance

Data Analysis

Statistical Control Techniques

Risk Management

Educación

Bachelor's degree in Industrial Engineering

Herramientas

ISO 13485

ISO 14971

Descripción del empleo

This is where you save and sustain lives

At Baxter, our mission deeply connects us. Regardless of your role, your work positively impacts people worldwide, providing a sense of purpose as we improve outcomes for millions of patients.

Baxter's products and therapies are present in nearly every hospital, clinic, and home globally. For over 85 years, we have pioneered medical innovations that transform healthcare.

We foster a workplace where happiness, success, and inspiration thrive. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your role at Baxter:

Coordinates scheduling and control of quality resources and compliance with specifications for raw materials, products, packaging, and regulatory agencies. Manages ongoing regulatory compliance, including quality systems.

Supports resources and quality functions related to sustainment projects under supervision, establishing and maintaining systems through quality control standards and procedures for your area.

Supports quality resources and functions related to sustainment projects under supervision.

What you'll do:

1. Ensure compliance with QSR regulations part 820, ISO-13485, and other applicable regulations.
2. Report metrics to monitor quality performance.
3. Manage non-conforming material processes according to established procedures and metrics.
4. Assist in creating, maintaining, and improving work instructions.
5. Support validation activities, including IQs, TMVs, OQs, PQs for designated areas.
6. Lead or participate in NCR, SNCR, CAPA activities following established procedures and ensuring quality objectives are met.
7. Help implement statistical control techniques to improve efficiency and effectiveness.
8. Analyze data from field reports to investigate and resolve issues identified through Post Market Surveillance.
9. Participate in project transfers by identifying and correcting manufacturing process gaps, establishing acceptance criteria, and supporting compliance with project deadlines.
10. Engage in Value Stream projects for quality improvements, cost savings, and increased productivity.

What you'll bring:

• 3 to 5 years of quality experience
• Advanced level of English
• Bachelor's degree in Industrial Engineering or related field
• Training/knowledge in risk management ISO 14971 and ISO 13485

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities. If you need an accommodation during the application or interview process, please click here and provide your contact details.

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