Summary
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. Integral assessments across sites and management of CAPAs.
Detailed Description
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 communication skills are essential

Knowledge/Skills/Competencies
- 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

📌 Manager, Global QMS (Nuevo León)
🏢 Celestica
📍 Nuevo León