Let's talk about the team:The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer's quality requirements.Let's talk about Responsibilities:Support the Factory Focus teams to achieve current KPI of Quality, Delivery and CostParticipate 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 teamPro-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 sitesEnsure risk of non-compliance and related business risks are mitigatedProvide quality / technical guidance through mentoring / trainingEnsure compliance to ResMed QMS and overall compliance to applicable regulatory standardsBuild positive working relationships with internal and external customers to ensure QA purpose and vision is recognized as integral to business success and growthFoster/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.Let's talk about you:Required:Bachelor's degree in Engineering or Science with 3 years' experience in a regulated volume manufacturing industry. Experience or exposure in Quality Systems / Manufacturing quality, risk management, process validation Self-starter, with the ability to work with minimal supervision and with a sense of urgency. 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 methodologiesJoining 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!
