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 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. 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 activities and CAPA evidence for completeness prior to closure. As required, support and represent ResMed in external audit situations through audit preparation, facilitation and acting as a direct auditee when required, including supporting the preparation of formal responses to external audits ready for management review prior to submission. Recommend opportunities for the continual improvement of the audit system in accordance with best practice and individual analysis of specific ResMed needs and support implementation. Work with corresponding QA teams in other parts of ResMed to ensure that the audit, CAPA and general Quality Systems are aligned to facilitate global deployment where appropriate. Support the maintenance of QA supplier management and ongoing monitoring activities to facilitate effective supply chain management and ensure external regulatory compliance requirements are met. Undertake other QA project and ad hoc activities as required. Travel as needed, approximately 10%. Qualifications and Experience Required Bachelor Degree in Engineering or Science Strong listening, verbal and written communication skills. Experience with Quality Systems within a Medical or similarly regulated industry. Moderate audit experience. Preferred Minimum 3 years applied professional quality assurance experience ideally including the medical industry or similar regulated industry. Formal Training in Quality Systems audits. Formal Six Sigma and analytical problem-solving training and application experience. Knowledge and coverage of ISO13485 and FDA 21 CFR Part 820 requirements. Acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types. We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees accrue three weeks Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members. Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills. At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range for this position is: $68,000 to $102,000. #J-18808-Ljbffr