The primary role of the Quality Assurance - Quality Systems function is to ensure that management systems are established to enable business compliance with multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements.
The Quality Assurance - Quality Systems function supports all aspects of the audit program to ensure regulatory compliance, quality best practice, process improvements and development of supplier quality systems; provides broad business technical support around QA systems and processes to the organization; supports and implements significant quality projects across the business and creates and improves quality and business processes
Let’s Talk About Role
• Support preparation of and implement a comprehensive internal and supplier audit program that meets the requirements of the business and applicable external regulatory bodies.
• Project-manage the activities resulting from... observations and non-conformances raised during internal audits and as part of CAPA investigations. Liaise with stakeholders and drive these findings to effective and timely closure.
• As required, support and represent ResMed in external audit situations through audit preparation, facilitation and acting as a direct auditee when required.
• Support the management, maintenance, and optimisation of the structure and integrity of the Global Quality Management Systems (QMS) to ensure compliance and alignment with applicable regulations, standards, and business requirements.
• Support in the consultation and collaboration with Global Business Process owners to interpret, construct and apply robust processes into the Global QMS.
• Support the implementation of a Global QMS.
• Review, analyse and implement opportunities for continual improvement of the Global QMS to meet business needs.
• Provide reports and metrics to management on the status of the Audit and Global QMS programs and provide an assessment of the possible resulting business impact.
• Build strong networks and work with teams in other ResMed locations to ensure that Quality Assurance systems/processes are in alignment globally.
• Undertake other Quality Assurance Systems support and other ad hoc activities as required, including Audits and QMS support.
Let’s Talk About You
• Bachelor’s degree in Science or Engineering.
• Experience of ISO13485 and 21 CFR Part 820 requirements.
• Minimum 2 years applied professional quality assurance experience ideally including the medical industry.
• Formal training and experience in Quality Systems audits. Moderate audit experience.
• Strong listening, verbal, and written communication skills.
• The ability to identify linkages and dependencies between processes.
• Experience in the maintenance of Management Systems including ongoing improvement of systems and processes.
• Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
• Ability to successfully influence others to achieve outcomes.
• Agility to adapt and respond quickly while being resilient to overcome obstacles.
• Experience in process improvement and value stream mapping.
• Acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types.
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
Sydney NSW Australia