Quality Auditor
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Job Description
Quality Auditor ensuring ResMed medical-device compliance through supplier and internal audits. Managing CAPA findings, regulatory responses, and Quality Systems improvements.
Responsibilities:
- Support preparation and implementation of a comprehensive supplier and internal audit program
- Provide management reports on audit and CAPA program status and assess possible business impact
- Project manage activities resulting from audit observations and CAPA investigations
- Liaise with stakeholders and drive findings to effective and timely closure
- Review and interpret audit observations and CAPA evidence for completeness before closure
- Support and represent ResMed in external audits, including preparation, facilitation, and acting as a direct auditee
- Support preparation of formal responses to external audits for management review
- Recommend and implement continual improvements to the audit system
- Collaborate with QA teams across ResMed to align audit, CAPA, and Quality Systems for global deployment
- Maintain QA supplier management and monitoring activities
- Undertake QA projects and ad hoc activities
- Provide broad technical support for QA systems and processes
- Support quality projects and create or improve quality and business processes for compliance and continuous improvement
Requirements:
- 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
- Minimum 3 years applied professional quality assurance experience ideally including the medical industry or similar regulated industry (preferred)
- Formal Training in Quality Systems audits (preferred)
- Formal Six Sigma and analytical problem-solving training and application experience (preferred)
- Knowledge and coverage of ISO13485 and FDA 21 CFR Part 820 requirements (preferred)
- Experience acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types (preferred)
- Ability to travel as needed, approximately 10%
Benefits:
- Comprehensive medical, vision, dental, and life insurance
- AD&D insurance
- 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)
- Tuition assistance
- Three weeks Paid Time Off (PTO) in the first year
- 11 paid holidays plus 3 floating days
- 14 weeks of primary caregiver or two weeks of secondary caregiver leave
- Flexible work arrangements
- Competitive salaries
- Opportunities for personal and professional growth
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