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

Bachelors degree in Engineering Science or related technical discipline
710 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 Teleflexs 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%