About the Job
We are seeking an experienced Quality Management System (QMS) Engineer to join our team at GxPeople Global. As a QMS Engineer, you will play a key role in supporting the development and implementation of our QMS processes.
Your responsibilities will include supporting quality-driven technology projects, developing and updating QMS procedures, and ensuring compliance with ISO 13485:2016 and other global requirements.
* Support quality-driven technology projects.
* Develop and update QMS procedures and associated Work Instructions.
* Ensure compliance with ISO 13485:2016 and other global requirements.
Responsibilities:
* Manage and maintain CAPAs.
* Conduct internal and supplier audits.
* Plan and conduct internal and supplier audits.
* Contribute to product Risk Assessment.
* Train cross-functional teams in using advanced quality planning tools.
* Support device testing activities.
Requirements:
* Experience in Medical Device Manufacturing.
* Working knowledge of ISO 13485:2016 and MDSAP.
* Lead Auditor trained and certified.