Let’s talk about Responsibilities

Support the Factory Focus teams to achieve current KPI of Quality, Delivery and Cost

Participate and support new products introduction process into manufacturing with active involvement in appropriate XFT deliverables and phase transitions in collaboration with QA counterpart in XFT and QA/RA team

Pro-actively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and sites

Ensure risk of non-compliance and related business risks are mitigated

Provide quality / technical guidance through mentoring / training.

Ensure compliance to ResMed QMS and overall compliance to applicable regulatory standards

Build positive working relationships with internal and external customers to ensure QA purpose and vision is recognized as integral to business success and growth

Foster/promote a quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements and provide coaching and guidance to PFT on an ongoing basis.

Perform or support internal / external / supplier audits

Let’s talk about Qualifications and Experience

Required

Bachelor’s degree in Engineering or Science with 3 years’ experience in a regulated volume manufacturing industry. 

Experience / exposure in Quality Systems / Manufacturing quality, risk management, process validation 

Independent and proactive learner, with the ability to work under guidance of other senior team members

Good planning and organisational skills; ability to take own initiative and ownership. 

Preferred

Experience in Quality and/or Regulatory positions in medical device industry.

Experience in quality system, manufacturing quality, process validation and risk management methodologies

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!