Andrew Tong

About Andrew Tong

Quality Engineer driven to bring medical solutions to life.

Experience

1. Quality Systems Engineer Ii

   Teleflex

   Dec 2023 — Present · Morrisville, NC, US

   Provide technical support for enterprise-wide Quality Management System (QMS) harmonization and electronic QMS (eQMS) implementation, ensuring alignment with FDA 21 CFR 820, EU MDR, and ISO 13485.• Support cross-functional workshops to map processes, identify gaps, and implement improvements, reducing process redundancies across multiple functions.• Author and revise global SOPs, work instructions, and forms to support QMS harmonization, resulting in consistent compliance practices across enterprise sites.• Develop and deliver training materials adopted by employees globally, improving QMS adoption rates and audit readiness.• Collaborate with leadership teams and shared services to configure eQMS workflows; contribute to design reviews, user workshops, and user acceptance testing, leading to streamlined system configuration.• Support organizational change management for QMS initiatives, enabling smoother transition across facilities and improving compliance consistency.• Collect and analyze raw data to monitor project metrics, delivering actionable reports to Project and Program Managers that influence decision-making.

Education

• North Carolina State University

  Bachelor’s Degree, Biomedical/Medical Engineering

  2014 — 2018

Skills

• Social Media
• Microsoft Word
• Management
• Team Building
• Powerpoint
• Microsoft Excel
• Research
• Customer Service
• Leadership
• Public Speaking
• Strategic Planning
• Microsoft Office
• Sales