Quality Auditor (US Remote)

ResMed

1d•$68,000 - $102,000•Remote

About The Position

The Quality Auditor supports ResMed’s Quality Assurance function by ensuring management systems enable business compliance with applicable regulatory frameworks and support the design, development, and manufacture of products that meet customer quality requirements. ResMed products and design and manufacturing operations must comply with medical-device regulations in their markets, including FDA requirements in the United States, relevant European competent authorities, ISO 13485, MDSAP requirements, and European Union Regulations. The role interacts with suppliers, external auditors, and internal departmental managers. It is responsible for auditing to support regulatory compliance, quality best practices, process improvement, and supplier quality system development. The Quality Auditor also provides technical support on QA systems and processes, supports and implements quality projects across the business, and creates and improves quality and business processes for compliance and continuous improvement. The position is US remote and requires approximately 10% travel as needed.

Requirements

Bachelor’s 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.

Nice To Haves

At least 3 years of applied professional quality assurance experience, ideally including the medical industry or a similar regulated industry.
Formal training in Quality Systems audits.
Formal Six Sigma and analytical problem-solving training and application experience.
Knowledge and coverage of ISO 13485 and FDA 21 CFR Part 820 requirements.
Experience acting as a lead or experienced supporting auditor for internal and supplier audits across a range of relevant processes and supplier types.

Responsibilities

Support preparation of and implement a comprehensive supplier and internal audit program that meets business requirements and applicable external regulatory requirements.
Report to management on the status of audit and CAPA programs and assess possible business impacts.
Project-manage activities arising from internal audit observations and CAPA investigations, liaising with stakeholders and driving findings to effective and timely closure.
Review and interpret audit observation activities and CAPA evidence for completeness before closure.
Support and represent ResMed during external audits as needed, including audit preparation, facilitation, serving as a direct auditee, and supporting preparation of formal responses for management review before submission.
Recommend and support implementation of continual improvements to the audit system, based on best practices and ResMed’s needs.
Work with QA teams across ResMed to align audit, CAPA, and general Quality Systems for global deployment where appropriate.
Support maintenance of QA supplier management and ongoing monitoring activities to facilitate effective supply chain management and meet external regulatory requirements.
Undertake other QA project and ad hoc activities as required.
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 of accrued Paid Time Off (PTO) in the first year of employment.
11 paid holidays and 3 floating days.
14 weeks of primary caregiver leave or 2 weeks of secondary caregiver leave when welcoming new family members.
Flexible work arrangements.