Quality Auditor

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.