Expected Travel: Up to 10%

Requisition ID: 13709

Position Summary

The Senior Logistics and Distribution Quality Manager is responsible for the leadership, development, implementation, and continuous improvement of the Quality Management System (QMS) within the North American Distribution Center (NADC). This role ensures compliance with ISO 13485, FDA regulations (including 21 CFR Part 820), and applicable global regulatory requirements.
The position provides strategic and operational quality leadership across distribution and logistics processes, ensuring product quality, regulatory compliance, and audit readiness. The role leads a multi-level quality team and partners cross-functionally with Operations, Supply Chain, and Global QA to drive performance, mitigate risk, and support safe patient outcomes.

Principal Responsibilities

Quality System Leadership
• Own and maintain the NADC Quality Management System in alignment with ISO 13485 and FDA regulatory requirements
• Serve as the designated Quality Management Representative for the NADC
• Ensure QMS processes are established, implemented, maintained, and continuously improved
• Promote awareness of regulatory and customer requirements across the organization

Regulatory Compliance & Audit Readiness
• Ensure compliance with applicable FDA regulations (21 CFR Part 820), ISO 13485, and other global requirements
• Manage internal, external, and corporate audits, including FDA and notified body inspections
• Provide front-room and back-room audit support as required
• Maintain and continuously improve the internal audit program and product inspection processes

Quality Operations & Inspection
• Establish, implement, and optimize inspection methods, sampling strategies, and quality inspection processes
• Ensure appropriate qualification, preventive maintenance and calibration of inspection and processing equipment
• Oversee product quality decisions and disposition activities within distribution operations
• Support Operations teams in addressing quality issues and ensuring compliance

Performance Management & Continuous Improvement
• Define, implement, and monitor Quality KPIs (e.g., deviations, CAPA effectiveness, audit outcomes, etc.)
• Routinely report on QMS performance and quality metrics to senior management
• Drive continuous improvement initiatives across distribution and logistics processes
• Lead and support CAPA, nonconformance, and risk mitigation activities

Leadership & Cross-Functional Collaboration
• Lead, coach, and develop Quality Inspectors, Technicians, and Engineers
• Partner effectively with Operations, Business Units and Global QA to align on quality programs and objectives
• Foster a culture of accountability, compliance, and continuous improvement at NADC
• Support business needs and strategic initiatives as required

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

Education / Experience Requirements
• Bachelor's degree in Engineering, Science, or related technical discipline
• 10+ years of progressive experience in medical device or pharmaceutical quality systems
• Demonstrated experience in distribution, logistics, or supply chain quality environments
• Proven experience interacting with FDA and notified bodies during inspections and audits
• Prior leadership experience managing quality teams required
• ASQ certification (CQE, CQA, CMQ/OE) preferred

Specialized Skills / Other Requirements

The Senior Logistics and Distribution Quality Manager, NADC 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
• Own quality and compliance risks within the NADC distribution environment
Collaboration & Respect
• Foster open communication and maintain professionalism and mutual respect at all times
• 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 and new processes and systems
• 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

#LI-EB1

Working Conditions / Physical Demands

TRAVEL REQUIRED: Estimated 5-10%

WORKING ENVIRONMENT:
☒ Office/Professional ☒ Plant/Manufacturing • Remote/Field • Laboratory

The description above represents the most significant duties of this role but is not all inclusive. Other work assignments comparable to the level of responsibility indicated above may be required.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.