Senior QA Specialist - Medical Devices

About the company

A global leader in medical technology who are patient-focused and passionate about their work. They research and develop innovative devices for use in heart disease and critical care.

About the opportunity

As the Senior QA Specialist, you will be responsible for ensuring the standard of quality is met for high-risk medical devices. This is a unique and varied quality role which will involve liaising with the Business Units, ensuring compliance of the Quality Management System and quality inspections.

The ideal candidate will be a people person with leadership qualities and strong technical experience in a QA role within the medical device industry.

Duties

• Develop and maintain Quality Management System according to company and local regulatory requirements
• Implement and maintain product inspection process and product release process, including Imported Finished Goods, Over-Labelled Products, and Returned Products
• Drive improvements for company and 3PL Quality Management Systems
• Responsibility for implementing quality agreements
• Provide quality training
• Responsibility for Non-Conformance, CAPA processes and risk assessment process
• Handling product complaints; reporting, investigations, response

Skills and Experience

• Tertiary qualifications in Life Science, Engineering, or Quality
• 5 -10 years QA experience in a highly regulated environment
• Experience in a quality and/or manufacturing environment in the medical device industry
• Leadership experience
• Full understanding of medical devices regulations: ISO13485 and local regulatory requirements
• Ability to manage competing priorities in a fast-paced environment
• Must be flexible to travel as required

How to Apply

Click apply or contact Joanna Murphy, Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )