Quality Systems Leader: CAPA, Audits & Compliance

Baxter International

Tijuana

On-site

MXN 1,000,000 - 1,500,000

Full time

2 days ago

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Job summary

Baxter International is seeking a Manager, Quality Systems to provide strategic leadership for the site's Quality Management System and ensure ongoing compliance with global regulatory requirements. You will lead a high-performing team responsible for CAPA, internal audits, document control, training, and governance, delivering safe, effective products worldwide.

You will partner with manufacturing, engineering, regulatory, and product development teams to support new product introductions and

Qualifications

Bachelor's degree in Engineering or related technical discipline.
8+ years in medical device or regulated manufacturing.
4+ years of people leadership experience.
Strong knowledge of QMS and global quality standards (FDA 21 CFR Part 820, ISO 13485).
Experience leading regulatory, customer, and notified body audits.
Advanced English communication skills.
Ability to influence cross-functional stakeholders and drive improvements.

Responsibilities

Lead continuous improvement of the Quality Management System.
Drive quality objectives and KPIs; mitigate risks.
Champion quality culture through coaching leaders.
Oversee CAPA, internal audits, document control, training, and governance.
Lead interactions during audits with customers/regulators/notified bodies.
Partner with manufacturing, regulatory, product development for new product introductions and process validation.
Develop and lead a high-performing team through coaching and succession planning.