10 - Manager, Operations Quality 2

Celestica; Xico; On-site; MXN 900,000 - 1,500,000; Full time

Job summary

Celestica busca un Gerente de Operaciones de Calidad para liderar la gobernanza técnica de calidad en un entorno regulado. Coordinará pilares clave de sterilización, microbiología y sistemas de ingeniería, enfocándose en la salud del sistema y la reducción de errores.

El rol requiere más de 10 años en calidad, experiencia en proyectos de liberación automatizada y gestión de auditorías. Se valorará capacidad de liderazgo y desarrollo de personal.

Qualifications

• Experiencia mínima en ingeniería de calidad en dispositivos médicos o entornos regulados.
• Conocimiento de normas ISO 13485, FDA 21 CFR 820 y sistemas de calidad.
• Habilidad para dirigir equipos y gestionar riesgos.

Responsibilities

• Liderar la autoridad técnica centralizada en calidad.
• Impulsar salud del sistema y métricas de calidad para reducir errores humanos.
• Gestionar PFMEA y respuestas ante auditorías regulatorias.
• Promover iniciativas de inspección inteligente para eficiencia operativa sin incrementar headcount.

Skills

Regulatory compliance

Gestión de calidad

PFMEA

SPC

MSA

PPAP

QA Management

CAPA management

Mejora continua

New Product Introduction

Auditorías regulatorias

Desarrollo de personal

Education

Ingeniería (B.S.)

Tools

IQ/OQ/PQ

Job description

10 - Manager, Operations Quality 2

Empresa : Celestica Tipo de empleo : Tiempo completo Monterrey, Mexico

Descripción del trabajo - 10 - Manager, Operations Quality 2

Req ID: 137249

Remote Position: No

Region: Americas

Country: Mexico

State/Province: Nuevo Leon

City: Monterrey

General Overview

Functional Area: Quality (QUA)

Career Stream: Operations Quality (OPQ)

Role: Manager 2 (MG2)

Job Title: Manager, Operations Quality 2

Job Code: MG2-QUA-OPQ

Job Level: Level 10

Direct/Indirect Indicator: Indirect

Summary

Position Summary

We are seeking a highly technical, strategic Quality Technical Services (QTS) Hub Manager (Band 10) to lead our newly centralized technical quality command . This critical leadership role uncouples deep technical engineering investigations from day-to-day administrative burdens . You will directly oversee high-risk, high-impact manufacturing and regulatory support pillars, shifting the site toward a proactive system health model .

Physical Demands

• Must be able to access and move safely within cleanroom environments, microbiology laboratories, and manufacturing production lines .
• Standard office environment tasks, including extended periods of sitting, computer line-of-sight operations, and collaborative cross-functional reviews

Knowledge/Skills/Competencies

Mandatory Qualifications & Background:

• Regulatory Compliance: Proven, deep hands-on expertise operating within ISO 13485 certified and FDA-registered facilities .
• Domain Competencies: Demonstrated on-the-job experience across critical quality pillars including: Sterilization Assurance, Environmental Control/Microbiology, New Product Introduction (NPI), Project Management, Quality Management Systems (QMS), Continuous Improvement (CI), CAPA Management, Advanced Process Controls, Internal/External Regulatory Audits, Customer Complaints Management, Quality Core Tools (PFMEA, SPC, MSA, PPAP), and strategic Personnel Development

Detailed Description

The right Candidate for this position holds:

• Advanced knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 11135 / 11137 (Sterilization standards) .
• Proven track record of managing automated product release projects, validating production equipment (IQ/OQ/PQ), and optimizing quality inspection parameters (Smart Inspection) .
• Strong leadership capability with a demonstrated history of expanding cross-functional team exposure and accelerating the development/coaching of personnel .
• Excellent technical writing skills for standardizing technical reports, addressing regulatory inquiries, and managing technical risk assessments (PFMEAs) .
• Sharp analytical, communication, and presentation skills to effectively interface during high-pressure regulatory audits

Typical Experience

Experience: 10 + years of recent, progressive professional experience in Quality Engineering or Quality Operations, with a minimum of 5 years in a direct supervisory or managerial capacity managing technical contributors/engineers within the Medical Device field according to the responsabilites listed below:

Centralized Technical Authority: Provide strategic leadership and technical governance over Sterilization Assurance, Microbiology/Laboratory Services, and Technical Systems Engineering .

Proactive System Health: Deploy advanced Quality Engineering expertise to focus on automated release projects, standardized technical reporting, and system health metrics to aggressively reduce human error .

Risk De-risking: Lead engineering efforts to drive proactive Process Failure Mode and Effects Analysis (PFMEA) updates and provide immediate technical governance during site-critical manufacturing events .

Efficiency & Optimization: Champion "Smart Inspection" initiatives to increase operational efficiency across manufacturing lines without adding headcount

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.

Typical Education

Bachelor of Science (B.S.) degree in Engineering (Biomedical, Chemical, Mechanical, or Electronics) or a hard scientific discipline (Microbiology, Biochemistry, or related Life Sciences field) or demonstrated equivalent experience.

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.

COMPANY OVERVIEW:

Celestica, Inc. (NYSE: CLS; TSX: CLS) is a technology leader dedicated to driving customer success and market advancements. With deep expertise in design, engineering, manufacturing, supply chain, and platform solutions, Celestica enables critical data center infrastructure for AI, cloud, and hybrid cloud and advances technologies in high-growth markets. With a talented team and a strategic global network, Celestica helps its customers achieve competitive advantages.

Today, Celestica delivers innovative supply chain solutions globally to customers in strategic two operating and reporting segments: Advanced Technology Solutions (ATS) and Connectivity and Cloud Solutions (CC):

ATS: This segment serves customers in complex, regulated & high-reliability markets such as Industrial & Smart Energy, Aerospace & Defense, Semiconductor Capital Equipment, and HealthTech. It is engineering led, with deep expertise in design, manufacturing and lifecycle solutions.

CCS: This segment focuses on high-performance technology solutions and services for the data center, serving hyperscalers, digital native customers and enterprises. Celestica's Platform Solutions offering provides innovative and customizable computing, storage and networking solutions enabling AI-driven growth.

Built on a legacy of trust and performance, Celestica has earned its reputation by delivering results in complex and fast-changing markets. Celestica exceeds customer expectations by identifying trends and staying ahead of the curve. Backed by comprehensive capabilities and a global network across North America, Europe and Asia, Celestica helps customers gain competitive advantage with the quality, flexibility and resiliency they need to respond quickly to shifts in demand. Guided by a bold vision to accelerate market advancements, Celestica delivers innovative solutions and technologies that turn complexity into opportunity. Anchored in teamwork and commitment, Celestica strives to be the most trusted partner to its customers and colleagues worldwide.

Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.