Global L&D Quality Manager, Supplier Quality and Shipholds

Expected Travel: Up to 10%

Requisition ID: 13678

 

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
 
At Teleflex, we are empowering the future of healthcare.  For more information, please visit teleflex.com.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This role ensures compliance with ISO 13485, ISO 9001, FDA regulations (21 CFR Part 820), and applicable Medical Device Regulations. The position serves as the global Subject Matter Expert (SME) for the Ship Hold process and supports consistent deployment across regions and distribution centers.
The role partners cross-functionally with Distribution Centers, Manufacturing, Regulatory Affairs, and Global QA to support compliance, mitigate risk, and maintain business continuity. This position also serves as the Deputy Management Representative for the NADC, providing support and backup to the Senior Logistics and Distribution Quality Manager as needed.

Principal Responsibilities

Quality Systems Support & Compliance
•    Support compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 820, and applicable Global Medical Device Regulations 
•    Assist in maintaining and improving assigned QMS processes to ensure effectiveness and consistency 
•    Support ongoing compliance and inspection readiness activities including front room/backroom support

Global Ship Hold Process (SME & Coordination)
•    Serve as Subject Matter Expert (SME) for the global Ship Hold process 
•    Support the development, standardization, and maintenance of Ship Hold procedures 
•    Coordinate Ship Hold activities across regions and distribution centers 
•    Provide guidance to regional Ship Hold Coordinators (direct and/or dotted-line relationships) 
•    Ensure timely escalation, tracking, and resolution of Ship Hold events 
•    Monitor and report Ship Hold metrics and trends

Supplier Quality & Quality Systems Administration
•    Support the development and maintenance of Quality Agreements with suppliers and partners 
•    Support Distribution Center (DC) and 3PL audit processes 
•    Assist with internal audits and regulatory inspections related to supplier and distribution quality processes 
•    Ensure quality system documentation and processes are maintained appropriately

Regulatory Compliance & Audit Support
•    Support internal audit execution and audit readiness activities 
•    Participate in FDA, ISO, and other regulatory inspections as required 
•    Support timely closure and effectiveness of audit observations and corrective actions

Distribution & Site Support
•    Support Distribution Centers in resolving local quality and compliance issues 
•    Provide guidance on quality system requirements and issue resolution 
•    Support the Quality Management Review (QMR) processes and other key QMS elements as required

Performance Management & Continuous Improvement
•    Support development and monitoring of quality metrics related to Ship Hold, supplier quality, and distribution processes 
•    Analyze data to identify trends and support proactive improvement initiatives 
•    Contribute to continuous improvement efforts across quality systems and processes 

Quality Systems Projects & Cross-Functional Support
•    Support MDR-related activities and ongoing regulatory compliance requirements 
•    Participate in quality system-related projects and improvement initiatives 
•    Assist in identifying process gaps and implementing improvements