SummaryResponsible 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 general 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.
Responsibilities
- 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), managing the inspection readiness program.




- Improve HT quality agreement templates and processes; support site quality leaders in negotiations and approval of quality agreements; lead internal supplier agreements across sites.

Travel RequirementsTravel to foreign countries is required; travel requirements greater than 50%. A passport is necessary.
Qualifications
- 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 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; direct participation in FDA inspections.
- Understanding of medical device statutes, standards and regulations to discuss, apply and re

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