Job Description

****Must have a background in medical device environment****

Overview:

The Quality Manager is responsible for the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure full compliance with applicable . and international regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 27001, and other applicable regulatory requirements.

This position supports both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices. This is a permanent opportunity offering hybrid working once probation is passed.

Responsibilities:

  • Own and lead the Quality Management System for the division, ensuring ongoing compliance with FDA, ISO, and other global regulatory requirements.
  • Ensure QMS effectiveness through performance monitoring, management review, and continuous improvement ...

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