Senior Quality Manager

Baxter International Inc.; Monterrey; Vor Ort; MXN 900.000 - 1.600.000; Vollzeit

Zusammenfassung

Baxter International Inc. is seeking a Senior Quality Manager to provide strategic and operational leadership for the Quality organization at our Monterrey site.

The role focuses on patient safety, regulatory compliance, and continuous improvement, serving as a key member of the site QA leadership team and a Site QA Head designee. You will drive quality escalations, manage post-market quality processes, and lead cross-functional teams to strengthen the QMS and ensure alignment with FDA/ISO

Qualifikationen

• Bachelor’s degree in engineering, Life Sciences, or related technical discipline (Master’s preferred).
• 7+ years of experience in Quality Assurance/Quality Engineering in a regulated industry (medical device preferred).
• 3+ years in leadership or supervisory roles within QA/QC functions.
• Strong working knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.

Aufgaben

• Define and execute the site Quality strategy, ensuring alignment with business objectives, regulatory requirements, and global quality standards.
• Ensure effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) across all processes.
• Drive internal and external quality escalations, ensuring rapid containment, structured problem-solving, and effective communication with stakeholders, including leadership, customers, and regulatory bodies.
• Utilize data trending and signal detection to proactively identify risks and drive systemic improvements.
• Strengthening systems and processes to ensure audit readiness and sustained regulatory compliance.
• Lead, mentor, and develop the Quality organization, fostering a culture of quality ownership, accountability, and continuous improvement.
• Strengthen team capability in problem-solving, compliance, and quality systems execution.
• Promote a culture aligned with patient safety, regulatory excellence, and ethical standards.

Kenntnisse

Quality leadership

Regulatory understanding

Problem solving

Stakeholder communication

Ausbildung

Bachelor’s degree in engineering or Life Sciences

Master’s degree preferred

Jobbeschreibung

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.

#ThisIsWhereYourWorkMatters!

Your role:

The Senior Quality Manager provides strategic and operational leadership for the Quality organization, fostering a culture centered on patient safety, regulatory compliance, and continuous improvement. This role serves as a key member of the site QA leadership team and acts as a Site QA Head designee, ensuring consistent quality oversight, decision-making, and alignment with regulatory and business requirements.

The position leads internal and external quality escalations, oversees post-market quality processes, and drives proactive risk management and data-driven improvements across the product lifecycle. Through strong cross-functional collaboration, this role ensures effective resolution of quality issues, strengthens the Quality Management System (QMS), and enhances overall product quality and reliability.

What you'll be doing

• Define and execute the site Quality strategy, ensuring alignment with business objectives, regulatory requirements, and global quality standards.
• Ensure effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) across all processes.
• Drive internal and external quality escalations, ensuring rapid containment, structured problem-solving, and effective communication with stakeholders, including leadership, customers, and regulatory bodies.

• Utilize data trending and signal detection to proactively identify risks and drive systemic improvements.
• Strengthening systems and processes to ensure audit readiness and sustained regulatory compliance.

• Lead, mentor, and develop the Quality organization, fostering a culture of quality ownership, accountability, and continuous improvement.

• Strengthen team capability in problem-solving, compliance, and quality systems execution.

• Promote a culture aligned with patient safety, regulatory excellence, and ethical standards.

What you'll bring

• Bachelor’s degree in engineering, Life Sciences, or a related technical discipline (Master’s preferred)

• Minimum 7+ years of experience in Quality Assurance/Quality Engineering in a regulated industry (medical device preferred).
• 3+ years in leadership or supervisory roles within QA/QC functions.

• Strong working knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.

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.