Quality System Engineer

Updated: May 03, 2024 05:36 AM GMT

OrbusNeich Medical Company Ltd.

Hoevelaken

OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention.

Objective of the job

To make sure the products and processes in the manufacturing setting are consistent and meet both industry and client standards as well as legal demands. Responsible for maintaining standard operating procedures, quality management system in operations. Ensure all quality control and quality assurance standards are met. The Quality System Engineer reports to the site Quality Manager.

Tasks & Responsibilities
• detailed guidelines/procedures on what needs to be checked and what the quality standards are.
• our Quality Management System (QMS) with incidents, fixes and improvements.
• our systems based on ISO 13485 and/or MDR requirements. Support external and internal audits to implement actions and clarify programs and processes.
• production readiness review efforts essential for... More Detail