Manager, Quality Systems

190 Welch Allyn de Mexico, S. de R.l. de C.V. MEX; Tijuana; On-site; MXN 1,200,000 - 1,800,000; Full time

Job summary

Baxter in Mexico is seeking a Manager, Quality Systems to lead the site's Quality Management System, ensuring compliance with global regulatory requirements and industry standards. You will drive quality performance and support successful regulatory inspections to deliver safe, effective products worldwide.

You will mentor a high-performing team, coordinate audits with regulators and customers, and collaborate with manufacturing, regulatory, and product development to continuously improve

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 8+ years of experience in 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.

Responsibilities

• Lead the continuous improvement and simplification of the Quality Management System to enhance compliance, efficiency, and organizational performance.
• Drive quality objectives and KPIs, 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.

Skills

Quality management

Regulatory knowledge

Auditing

Leadership

Education

Bachelor's in Engineering

Job description

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.

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.

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.