QA Engineer

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!