CareerPlan

Senior Quality Manager

Monterrey, Nuevo León, MXFull-time2026-10-20 → 2026-11-10

Core

Strategic and operational leadership for the Quality organization, ensuring patient safety, regulatory compliance, and continuous improvement across the product lifecycle.

Role type

Senior Quality Manager (Site QA Head designee)

Builds

Quality Management System (QMS), risk management frameworks, and audit-ready processes

Domain

Medical device manufacturing / Regulatory Quality

Required skills

Quality strategy definition, QMS effectiveness, internal/external quality escalations, data trending and signal detection, audit readiness, team leadership and mentoring, regulatory compliance execution

Preferred skills

Master's degree in engineering or Life Sciences, experience in leadership roles within QA/QC

Technologies

FDA 21 CFR Part 820/11, ISO 13485

Responsibilities

Define and execute site Quality strategy aligned with business objectives; Ensure effectiveness and compliance of the Quality Management System (QMS); Drive internal and external quality escalations with structured problem-solving; Utilize data trending to proactively identify risks; Strengthen systems for audit readiness; Lead, mentor, and develop the Quality organization

Seniority

Senior, hands-on IC with leadership responsibilities