The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let’s talk about the team: 

The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.

Let’s talk about the role:

• Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external quality and regulatory standards requirements (i.e. ISO13485, MDSAP) for global distribution  

• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. 

• Provides engineering leadership by escalating and facilitating cross-functional investigations and resolution of product quality issues for components and finished medical devices. 

• Determine and process change requests and concessions.  

• Determine and process the disposition of non-conforming items.  

• Manage and report actions for products under QA on-hold. Collate information for meetings, ensuring assessment / reconciliation of stocks and mapping of corrective and preventive actions.  

• Facilitate the closure of field complaints & out of box failures.  Perform internal audits and assist with external quality system audits.  

• Determine and implement on-going improvements to the ResMed quality system and data reporting systems to support and improve current and future production and GMP compliance.  

• Assist in the introduction of new manufacturing areas, product, equipment and processes. 

Let’s talk about you: 

• Bachelor’s degree in engineering or science discipline.   

• Displaying leadership as the subject matter expert to collaboratively reach optimum decision on Quality and GMP issues.  

• Self-starter, with the ability to work with minimal supervision and with a sense of urgency.  

• Good planning and organisational skills.  

• Good communication skills.  

• Self-motivating, takes initiative and ownership.  

• Sets appropriate expectations and follows through with diligence.   

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!