QA Manager / QA Specialist - Medical Devices

To manage the Quality Management System by leading/ coordinating the following core activities;

* Establish direction, purpose and structure of the management system for medical devices
* Lead development and improvement activities
* Provide group/ senior management with clear performance information
* Resolve issues with products, processes and systems
* Provide technical guidance on regulations, certifications and approvals
* Implement and monitor targets, objectives and performance levels
* Review, revise and maintain the management system contents
* Lead and perform internal review activities such as audits, assessments etc
* Perform and control risk based assessments of products and processes
* Communicate the management system requirements/ expectations
* Consult with management team members on system needs/ gaps
* Communication and implementation of procedures and instructions
* Creating and maintaining product technical files and product records
* Monitoring applicable standards, regulations and publications within medical device requirements
* Liaising with customers and 3rd parties to resolve queries and issues
* Data collation/ preparation for regulatory reviews and evaluations
* Analyze process performance using the standard quality tool kit
* Identify and champion continuous improvement projects
* Oversee, manage and review test bay procedures and general activity

To manage the Environmental Management System by leading/ coordinating the following core activities;

* Lead environmental system development and improvement activities
* Provide group/ senior management with clear performance information
* Resolve potential issues with processes and systems
* Provide technical guidance on regulations, certifications and approvals
* Implement and monitor targets, objectives and performance levels
* Review, revise and maintain the management system contents
* Lead and perform internal review activities such as audits and assessments
* Communicate the management system requirements/ expectations
* Communication and implementation of procedures and instructions
* Monitoring applicable standards, regulations and publications
* Data collation/ preparation for regulatory reviews and evaluations

To apply directly for this position, please contact Rory Gummerson at Real Staffing Medical Devices team, by sending your CV

To find out more about Real Staffing please visit www.realstaffing.com