Global Quality Engineering Leader

A company is looking for a Global Quality Engineering Lead to establish and lead a new global Quality Engineering function within its Product Quality organization.

Key Responsibilities

Build and lead a global Quality Engineering function, developing a high-performing team and strategy

Establish standardized global procedures for process validation, statistical process control, and design transfer

Champion a data-driven approach to quality engineering and drive continuous improvement projects

Required Qualifications

Bachelor's degree in Engineering, Life Sciences, or related technical field; advanced degree preferred

6+ years of experience in quality engineering or manufacturing quality roles in the medical device or regulated life sciences industry

Expertise in process validation, statistical process control, and risk management

Strong understanding of FDA QSR / QMSR, ISO 13485, and other global regulatory requirements

Experience with quality systems software and continuous improvement methodologies