Quality Management Representative/PRRC stands for Quality Management Representative/Person Responsible for Regulatory Compliance - Eastborough, United States - Cascade Innovations

Cascade Innovations

Verified Company

Eastborough, United States

1 week ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

Your future role:

As our Quality Management Representative for ISO 13485, you will play a crucial role in ensuring compliance with quality management standards for both our company and our medical devices in Eastborough. You will oversee the development, implementation, and maintenance of our quality management system and ensure compliance with the requirements of ISO. Additionally, you will serve as the main point of contact between our organization and certification bodies, and act as the primary resource for your team members regarding our electronic Quality Management System (eQMS) and associated tasks and processes.

Your key responsibilities include:

Maintaining and further developing our quality management system in accordance with DIN EN ISO 13485, including:

Documentation management: You will be responsible for monitoring and maintaining our quality management system in accordance with legal requirements. We use an electronic QMS based on Atlassian Software (Confluence and Jira).

Auditing: You will plan and conduct internal and external audits, as well as customer and supplier audits, to ensure compliance with quality guidelines and identify process improvements in collaboration with external consultants and local authorities.

Training courses: To raise awareness of quality standards, you will conduct training courses for employees in quality management and serve as the first point of contact for any QM-related issues.

Ensuring that