Req ID: 138300
Remote Position: Hybrid
Region: Americas
Country: Mexico
State/Province: Nuevo Leon
City: Monterrey
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
Responsible for HT quality plan, culture initiatives and monitoring of objectives and KPIs. Own the global QMS training strategy; develop minimal requirements for training, onboarding and refresher training for all HT employees, assign, and track mandatory compliance training to ensure organization-wide competency. Improve and harmonize QMS policies across global sites to ensure consistency in compliance. Oversee the lifecycle of controlled documentation and data integrity. Manage the Corrective and Preventive Action (CAPA) system to ensure systemic issues are identified and closed. Global assessments across sites and management of CAPAs.
Quality Management System activities to assist in global 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 complaince 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.
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Proficiency in developing detailed protocols, such as CAPA reports, non-conformance records, and validation documentation, where technical accuracy is critical to patient safety and product quality.
- Excellent communication skills, both written and verbal, for presenting compliance strategies to senior management.
Regularly sitting/standing, free to move around.
Occasionally Sustained visual concentration on small areas, such as monitors, screens.
Regularly Sustained visual concentration on numbers, legal documents
Minimum of 7-10 years of experience in quality assurance/QMS role within the medical device industry, with at least 3 years 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 complaince 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.
Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related technical discipline. An advanced degree (Master's or MBA) is preferred.
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.
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 and 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.
