Job Overview
The Senior Quality Systems Engineer is responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
They will develop, implement, and continuously improve QMS processes, procedures, and instructions.
Key Responsibilities:
* Act as Subject Matter Expert (SME) for CAPA and Issue Evaluations, ensuring timely and effective closure.
* Lead and maintain the internal audit program and support external audits of the site.
* Host and manage regulatory inspections, including Notified Bodies (NBs) and FDA visits.
* Support change management activities, preferably using Windchill or similar Product Lifecycle Management (PLM) systems.
* Drive simplification of processes and implement innovative, technology-driven solutions, including AI-based tools for quality improvement.
* Prepare and lead Quality Management Reviews to ensure QMS effectiveness.
* Collaborate with operational/manufacturing groups and suppliers to resolve and prevent quality issues.
* Provide training and coaching on QMS requirements to business users.
What You'll Create Impact
As a Senior Quality Systems Engineer, you will make a significant impact on the organization by:
* Developing and implementing effective QMS processes that ensure compliance and quality excellence.
* Improving process efficiency and reducing costs through innovation and technology adoption.
* Enhancing the organization's reputation through successful regulatory inspections and audits.