Senior Quality Assurance Engineer - Audits

Job Summary

The primary role of the Quality Assurance – Quality Systems function is to ensure that management systems are established and maintained to enable business compliance with multiple regulatory frameworks and support the design, development and manufacture of products that meet customer quality requirements.

The function supports all aspects of the audit program to ensure regulatory compliance, quality best practice, process improvement and the development of supplier quality systems. It provides broad technical support across the business for QA systems and processes, supports and implements significant quality projects, and creates and improves quality and business processes.

Let’s talk about Responsibilities

• Prepare a comprehensive internal and supplier audit program that meets business requirements and applicable external regulatory body expectations.
• Support the global internal quality auditor program, including mentoring and coaching less-experienced auditors in their internal audit assignments.
• Work with business and process stakeholders to effectively implement the audit program and coordinate CAPA investigations with CAPA owners, as required.
• Ensure internal audits are conducted and followed up through effective corrective action implementation.
• Review audit findings for adequacy and the effectiveness of actions prior to closure.
• Project-manage activities required to prepare for external audits and address findings raised during external audits.
• Prepare formal responses to external audits for management review prior to submission.
• Review quality audit processes, policies and tools on an ongoing basis to ensure they remain relevant and valuable to the business.
• Provide management with reports on the status of the audit program, including an assessment of potential business impact.
• Develop and implement strategies for the continual improvement of the audit system, aligned with recognised best practice and informed by analysis of specific Resmed needs.
• Work with corresponding QA teams in other parts of Resmed to ensure audit systems are aligned and suitable for global deployment, where appropriate.
• Travel as required to conduct supplier and internal audits, and to support external audits.

Let’s talk about Qualifications and Experience

Required (Qualifications/experiences that are an absolute must for the position)

• Bachelor’s degree in science or engineering.
• Experience with ISO 13485 and 21 CFR Part 820 requirements.
• Minimum of 8 years applied professional quality assurance experience, ideally including experience in the medical device industry.
• Formal training and experience as a lead auditor for Quality Systems audits.
• Knowledge of Quality System requirements and their practical application in medical device manufacturing and development, including but not limited to QMSR, ISO 9001 and ISO 13485.

Preferred (Qualifications/experiences that are preferred for the position)

• Experience in a regulated industry associated with manufacturing or design, including ISO, MDSAP, FDA CFR, EU MDR and TGA requirements.
• Knowledge of Environmental Management Systems, including but not limited to ISO 14001.
• Experience in conducting supplier audits.
• Knowledge and application of Six Sigma, Lean methodologies, 8D and other problem-solving techniques.
• Moderate statistical analysis skills and experience applying AI tools or techniques.
• Strong listening, verbal, and written communication skills.
• Change management skills.
• The ability to identify linkages and dependencies between processes.
• Ability to think clearly and critically, assess information and evidence, and make informed, timely decisions.
• Agility to adapt and respond quickly, with resilience to overcome obstacles.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.