Manager, Quality Systems Tijuana, Baja California

Job description

Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. Support for Parents Continuing Education/ Professional Development Employee Health & Well-Being Benefits Paid Time Off 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. Detail Oriented Continuous Learner Courageous Collaborative Critical Thinker Influential Manager, Quality Systems Apply Now 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. Your Role at Baxter As the Manager, Quality Systems, you will provide strategic leadership for the site's Quality Management System while ensuring ongoing compliance with global regulatory requirements and industry standards. You will lead a high-performing team responsible for critical quality processes, including CAPA, internal audits, document control, training, and quality system governance. In this role, you will influence business outcomes by strengthening quality performance, driving sustainable process improvements, supporting successful regulatory inspections, and enabling the delivery of safe, effective products to customers worldwide. Your leadership will play a key role in advancing Baxter's commitment to quality, innovation, and patient care. What You'll Be Doing Lead the continuous improvement and simplification of the Quality Management System to enhance compliance, efficiency, and organizational performance. Drive quality objectives and key performance indicators, developing strategies that improve performance, mitigate risks, and deliver measurable business results. Champion a strong quality culture by coaching leaders and teams, building organizational capability, and fostering accountability across the site. Oversee quality system processes including CAPA, internal audits, document control, training programs, nonconformance management, and quality governance activities. Serve as the site's primary quality systems expert and lead interactions during customer, regulatory, and notified body audits, ensuring readiness and successful outcomes. Partner with manufacturing, engineering, regulatory, and product development teams to support new product introductions, process validation activities, and ongoing product quality improvements. Develop and lead a high-performing team through coaching, talent development, succession planning, and employee engagement initiatives that strengthen organizational capability. What You'll Bring Required Qualifications Bachelor's degree in Engineering or a related technical discipline. 8+ years of experience within the medical device, life sciences, pharmaceutical, or similarly regulated manufacturing industry. 4+ years of people leadership experience, with a proven track record of developing teams and achieving quality objectives. Strong knowledge of Quality Management Systems and applicable regulations such as FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and related global quality standards. Experience leading regulatory, customer, and notified body audits and managing quality system compliance activities. Advanced English communication skills, both written and verbal. Demonstrated ability to influence cross-functional stakeholders, solve complex problems, and drive continuous improvement initiatives. Preferred Qualifications Certified Lead Auditor training or equivalent experience supporting regulated quality systems. Experience with CAPA programs, risk management methodologies, process validation, and quality remediation initiatives. Background supporting medical device manufacturing operations, including sterile and/or non-sterile products. Experience preparing organizations for FDA, ANVISA, BSI, DQS, GMED, or similar regulatory and notified body inspections. Strong analytical, communication, stakeholder management, and change leadership capabilities. 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. 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 . Apply Now Address Explore this location Emilio Flores #2471-A Col. Cañon del Padre 22203 Tijuana, BCN Mexico Explore This Location Share LinkedIn Facebook X Email Hear from Our Employees Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world. Meet Christelle, Senior Quality Manager in Malta “I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.” Meet Lorena, Senior QA Associate in London, UK “I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.” Meet Gary, Quality Research Manager in Singapore “I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.” Related Content Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. Learn More March 28, 2024 People of Baxter Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve,