Quality Auditor

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. ResMed ’s products and our design and manufacturing operations must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States of America and the relevant competent authorities in Europe as well as applicable international standards such as ISO 13485 and those requirements prescribed in the Medical Device Single Audit Program (MDSAP) and European Union Regulations. The role will interact with stakeholders including suppliers, external auditors and internal ResMed departmental managers. Also, the role will be responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Providing broad business technical support around QA systems and processes to the organization. Supporting and implementing quality projects across the business and also creating and improving quality and business processes for compliance and Continuous improvement. Let’s talk about Responsibilities Support preparation of and implement a comprehensive supplier and internal audit program that meets the requirements of the business and applicable external regulatory bodies. Provide reports to management on the status of the audit and CAPA programs and provide an assessment of the possible resulting business impact. ​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. Review and interpret audit observation activitie