Senior Logistics and Distribution Quality Manager, NADC

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

Bachelors 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 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
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.