03 oct
|
Celestica
|
Monterrey
03 oct
Celestica
Monterrey
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11 - Senior Manager, Global Quality
Date: Sep 6, 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
Summary
Detailed Description
Quality Management System activities to assist in integral harmonization implementation to ensure compliance to 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 fully excution of the Quality Plan and objectives
Lead the HT CAPA process and indicators ensuring compliance across HT facilities.
Lead internal audit programs and lead for external regulatory inspections (FDA, Notified Bodies), lead the inspection readiness program.
Improve HT quality agreement templates and process,
support site Quality leaders in negotiations and approval of quality agreements, 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's leadership. Good communicaiton 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 role within the medical device industry, desired experience in a global or multi-site managerial capacity.
Required experience in Quality System (ISO 13485) applications of medical device manufacturing and/or design; Experience in Direct participation with FDA Inspections. Understanding of the medical device statutes, standards and regulations to discuss, apply and resolve complex issues of complai
📌 11 - Senior Manager, Global Quality (Monterrey)
🏢 Celestica
📍 Monterrey