Senior Quality Manager

Zvh; Monterrey; Presencial; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Baxter is seeking a Senior Quality Manager to provide strategic and operational leadership for the Quality organization. The role focuses on patient safety, regulatory compliance, and continuous improvement across the product lifecycle.

You will lead the QA team, manage quality escalations, and strengthen the QMS while ensuring alignment with global standards and regulatory bodies. This is a senior site leadership position.

Formación

• Bachelor’s degree in engineering or life sciences; 7+ years in QA/QE within a regulated industry.
• 3+ years in leadership or supervisory QA/QC roles.
• Strong knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.
• Strong knowledge of FDA 21 CFR Part 820/11 and ISO 13485.

Responsabilidades

• Define and execute the site Quality strategy aligned with regulatory requirements and global standards.
• Drive internal and external quality escalations and ensure audit readiness.
• Lead, mentor, and develop the QA organization with a culture of quality ownership.
• Use data trending to identify risks and drive systemic improvements.
• Ensure audit readiness and sustained regulatory compliance.

Conocimientos

Quality Leadership

Regulatory Compliance

Risk Management

Cross-functional Collaboration

Data-driven Improvement

Educación

Bachelor’s degree in engineering or life sciences

Master’s degree preferred

Herramientas

QMS

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.

#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.

#LI-GR1 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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. 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.