Quality Systems Leader – Medical Devices & Compliance

Zvh; 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

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