10 - Manager, Global QMS

Celestica Inc.; Monterrey; Presencial; MXN 1.200.000 - 2.100.000; Jornada completa

Descripción de la vacante

Celestica Inc. in Monterrey, MX seeks a Global QMS Manager to lead the Quality Management System activities for regulatory harmonization and compliance across sites.

This role trains HT employees, ensures execution of the Quality Plan, and leads CAPA processes with senior leadership interface. Travel >50% is required; strong communication and cross‑functional collaboration are essential.

Formación

• RequiresBachelor’s degree in Engineering or related field.
• 7–10 years in quality assurance/QMS in medical devices.
• Experience with ISO 13485 and FDA inspections.
• Ability to discuss and resolve complex regulatory compliance issues.

Responsabilidades

• Lead Quality Management System activities for global harmonization and regulatory compliance.
• Develop and train HT employees on quality requirements and awareness.
• Ensure execution of the Quality Plan and objectives.
• Lead CAPA process and metrics across HT facilities.
• Oversee internal audits and manage external regulatory inspections (FDA, Notified Bodies).
• Improve quality agreement templates and negotiate supplier quality terms; travel >50%.

Conocimientos

ISO 13485

FDA 21 CFR 820

Leadership

Regulatory audits

Cross-functional

Educación

Bachelor’s degree

Herramientas

CAPA tools

Descripción del empleo

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 global 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 clearly understand the risks of non‑compliance, including patient harm, company sanctions, fines and possible jail.

Proven track record of successfully leading major regulatory audits (FDA, Notified Bodies) and managing comprehensive QMS integrations.

Skills

• Expert knowledge of ISO 13485, FDA 21 CFR Part 820, Device Regulations (EU MDR) is a plus.
• Strong leadership and cross‑functional collaboration skills, with the ability to influence global teams.
• Excellent analytical and risk management capabilities (ISO 14971 familiarity is a plus).
• Ability to translate complex regulatory and procedural information into clear, accurate, and accessible documentation.
• Proficiency in developing detailed protocols such as CAPA reports, non‑conformance records, and validation documentation critical to patient safety and product quality.
• Excellent communication skills, both written and verbal, for presenting compliance strategies to senior management.

Physical Demands

Regularly sitting/standing, free to move around. Occasionally sustained visual concentration on small areas (monitors, screens). Regularly sustained visual concentration on numbers, legal documents.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.

Equal Opportunity Employment

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.