Quality Engineer

Sunrise Medical is an international company that is a world leader in the development, design, manufacture and distribution of manual and powered wheelchairs, mobility scooters and both standard and customized seating and positioning systems. 

Sunrise Medical Australia is the local region assembly and distribution centre. The company is located in Wetherill Park in western Sydney.

We are seeking a Quality Engineer to help run the quality system with a focus on manufacturing processes.

The Quality Engineer works in a manufacturing environment and is responsible for performing various quality and manufacturing activities on a variety of products.  They are responsible for manufacturing line implementation and qualification, customer complaints, RMA processes including receiving, data entry, inspection, evaluation and disposition of authorized returned goods.  They are supporting the inspection of purchased and internally manufactured parts, and assembled end items.  They also facilitate activities related to the identification, documentation, segregation, disposition, and control of nonconforming material in accordance with applicable Quality Management System Standards and regulatory requirements. Responsible for compliance to quality standards including, but not limited to, ISO 13485, ISO 9001 and TGA requirements.

• Manage manufacturing line implementation and qualification processes.
• Manage the NCR, CAPA, Customer Compliant Systems and RMA processes and support monthly FDA MDR reporting procedures.
• Coordinate and administer the control of QMS and DMR documents
• With assistance, maintain internal audits to schedule
• Maintain oversight of product release, completeness and archiving of DHR's.
• Maintain an oversight of the equipment control process
• Maintain an oversight of the training process of new and revised procedures and the training register
• Control the storage and archiving of expired or completed QMS and DMR documents
• Work within TGA, FDA and other applicable compliance requirements

• Experience in ISO9001, ISO13485, TGA and FDA regulatory framework
• Experience in ISO14001 (Highly desirable)
• Minimum of 5 years experience working with class I or class II medical devices
• Certificate IV in Engineering or equivalent qualification is required, bachelor degree in a technical field is preferred.
• Proven experience and knowledge of writing and controlling documents
• Proven experience in NCR and CAPA systems
• Practical and pragmatic problem solving. A hands-on "fixer" who works with others to resolve tasks and issues.