Gerente calidad

MEDTECH MEDICAL MEXICO; Salinas Victoria; Presencial; MXN 600,000 - 800,000; Jornada completa

Descripción de la vacante

A prominent medical technology company is seeking a Quality Control Manager based in Nuevo León, Mexico. The ideal candidate will have over 3 years of experience in quality management specifically in pharmaceuticals or medical devices, with strong leadership and analytical skills. Fluency in English is required, and familiarity with FDA audits is preferred. This position may involve travel. This role offers a competitive salary and opportunities for professional growth.

Formación

• 3+ years in quality management within pharmaceutical or drug-device combination products.
• Knowledge of pharmaceutical/medical device regulations and quality systems.
• Experience leading and responding to FDA audits.

Responsabilidades

• Drive problem-solving in quality contexts.
• Organize quality projects and develop team members.
• Manage internal alignment and regulatory interactions.

Conocimientos

Quality management experience

Fluent in English

Chinese communication skills

Analytical skills

Leadership

Educación

Bachelor’s degree in Biology, Pharmaceuticals, or related field

Descripción del empleo

Overview

Talent Profile: Quality Control Manager – Mexico

Core Qualifications

• 3+ years in quality management within pharmaceutical or drug-device combination products
• Fluent in English, (working proficiency in all communication modes), with Chinese skill would be prioritize
• Bachelor’s degree or higher in Biology, Pharmaceuticals, or a related field (from an accredited full-time program)

Technical Expertise

• Thorough knowledge of pharmaceutical/medical device regulations and quality systems, including demonstrated expertise in U.S. QSR (21 CFR Part 820)
• Good experience in critical process validation and control (e.g., Water systems, steam sterilization)

Professional Experience

• Direct experience leading and responding to FDA audits, preferably for high-risk medical devices
• Background in multinational companies; comfortable engaging with U.S.-based clients and stakeholders

Personal Attributes

• Strong analytical and risk-assessment skills with the ability to drive problem-solving in quality contexts
• Culturally aware and collaborative, able to integrate diversed points and work in international settings
• Excellent communicator: effective in internal alignment, client management, and regulatory interactions
• Proven leadership: able to organize quality projects, develop team members, and ensure local talent readiness.

-Requerimientos- Educación mínima: Educación superior - Licenciatura

• 5 años de experiencia
• Idiomas: Inglés
• Edad: entre 30 y 44 años
• Conocimientos: Digitalización de documentos
• Disponibilidad de viajar: Si
• Palabras clave: lider, jefe, gerente, manager, director, chief, lead, jefatura, regente, quality, qa