Quality Assurance Lead

Position Objective

The Quality Assurance Lead is responsible for developing, implementing and overseeing Quality Assurance and Quality Control activities, ensuring the effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, applicable GMP requirements, and EU MDR obligations.

This role provides operational leadership of the Quality function, combining quality system governance, manufacturing and cleanroom oversight, and people leadership. The QA Lead supports Clients transition from R&;D to scalable medical device manufacturing, ensuring quality compliance across production, validation, and inspection activities.

The QA Lead acts as the ISO 13485 Management Representative and Person Responsible for Regulatory Compliance (PPRC) ...