Global L&D Quality Manager, Supplier Quality and Shipholds

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 

Leadership & Collaboration
•    Provide direction and coordination to assigned team members and regional coordinators (including dotted-line relationships) 
•    Partner with Manufacturing, Regulatory Affairs, PMS, Supply Chain, and other functions as required 
•    Support a culture of compliance, accountability, and continuous improvement 
•    Act as backup/delegate for the Senior Logistics and Distribution Quality Manager as needed

Positions supervised may include but are not limited to:
o    Quality Specialists
o    Quality Technicians
o    Quality Engineers

Education / Experience Requirements

•    Bachelor’s degree in Engineering, Science, or related technical discipline 
•    7–10 years of experience in medical device or pharmaceutical quality systems 
•    Experience in supplier quality, distribution quality, and/or quality systems 
•    Experience supporting regulatory inspections (FDA, ISO, notified bodies) 
•    Experience working in cross-functional and/or global environments 
•    Prior leadership or matrix coordination experience preferred 
•    ASQ certification (CQE, CQA, CMQ/OE) preferred

Specialized Skills / Other Requirements

•    Working knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820, and applicable regulations 
•    Experience with CAPA, nonconformance management, and root cause analysis 
•    Understanding of supplier quality processes and quality agreements 
•    Ability to analyze and trend quality data to support decision-making 
•    Experience with eQMS systems and ERP/WMS platforms (e.g., SAP) 
•    Strong organizational, communication, and problem-solving skills 
•    Ability to influence cross-functional teams in a matrix environment 

LEADERSHIP EXPECTATIONS
The Global L&D Quality Manager, Supplier Quality and Shipholds must operate with a high standard of ownership, integrity, and technical/business acumen in Teleflex’s regulated, patient-focused environment. 
Accordingly, the following principles define how our team operates and defines what success looks like:

Patient-First Mindset
•    Make decisions grounded in data and objective analysis, not emotion 
•    Prioritize accuracy, efficiency, and productivity to support safe patient outcomes 
•    Execute work with urgency and reliability to meet operational and compliance requirements 

Accountability & Ownership
•    Deliver on commitments and take responsibility for results 
•    Proactively identify risks, communicate issues early, and implement effective solutions 
•    Make informed decisions and drive execution independently 
Collaboration & Respect
•    Foster open communication and maintain professionalism and mutual respect 
•    Promote a team-oriented environment where shared success is prioritized 
•    Build strong cross-functional partnerships to achieve organizational goals 
Continuous Improvement
•    Embrace continuous learning and adapt to evolving regulatory and business requirements 
•    Take ownership of processes and outcomes, ensuring sustainable improvements 
•    Drive initiatives that strengthen quality systems and elevate performance standards 
Compliance & Integrity
•    Adhere to all regulatory, quality, and ethical standards without exception 
•    Ensure compliance with internal policies and external regulatory requirements 
•    Demonstrate integrity in all actions and decision-making

TRAVEL REQUIRED: Estimated 0-10%