10 - Manager, Global QMS

Date: Jul 10, 2026

Location: Monterrey, NLE, MX

General Overview

Functional Area: Operations (OPS)
Career Stream: Quality (QUA)
Role: Manager 2 (MG2)
Job Title: Quality QMS Manager
Job Code: MG2-OPS-QUA
Job Level: Level 10
Direct/Indirect Indicator: Indirect

Detailed Description

Quality Management System activities to assist in general harmonization implementation to ensure compliance with applicable medical device regulations per jurisdiction, guidance and standards.

Develop and provide training for all HT employees ensuring training and awareness compliance across the HT organization.

Ensure full execution of the Quality Plan and objectives.

Lead the HT CAPA process and indicators ensuring compliance across HT facilities.

Lead internal audit programs and serve as lead for external regulatory inspections (FDA, Notified Bodies), and manage the inspection readiness program.

Improve HT quality agreement templates and processes, support site Quality leaders in negotiations and approval of quality agreements,



and lead internal supplier agreements across sites.

Travel to foreign countries is required, travel requirements greater than 50%. Passport is necessary. Position requires composure and ability to interface with Director leadership. Good communication skills are essential.

Education

Bachelor’s degree in Engineering, Life Sciences, Quality Management or a related technical discipline. An advanced degree (Master’s or MBA) is preferred.

Experience

Minimum of 7-10 years of experience in quality assurance/QMS roles within the medical device industry, desired experience in a global or multi‑site managerial capacity.

Required experience in ISO 13485 applications of medical device manufacturing and/or design; direct participation in FDA inspections. Understanding of medical device statutes, standards and regulations to discuss, apply and resolve complex issues of compliance with highly educated and professional teams. Able to clearl

📌 10 - Manager, Global QMS (Monterrey)
🏢 Celestica
📍 Monterrey