The primary role of the Quality Assurance, Quality Systems 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 ResMed’s customer’s quality requirements.
Requirements
- Minimum 5 years applied professional quality assurance experience ideally including the medical or other regulated industry including ISO 13485 and/or 21 CFR Part 820 requirements
- Experience in Training and Quality System audits. Lead Auditor experience.
- Experience in the maintenance of Management Systems including ongoing improvement of systems and processes.
- Experience in process improvement and value stream mapping.
- Formal Quality System Auditor training.
- Formal Training qualification or extensive training experience.
- Experience with Software as a Medical Device (SaMD)
Responsibilities
- Support the management, maintenance, and optimization of the structure and integrity of the Global Quality Management Systems (QMS) to ensure compliance and alignment with applicable regulatory standards and business requirements.
- Support in the consultation and collaboration with Global Business Process owners to interpret, construct and apply robust processes into the Global QMS.
- Support the implementation of a Global QMS.
- Review, analyses, and implement opportunities for continual improvement of the Global QMS to meet business needs.
- Provide reports and metrics to management on the status of the Audit and Global QMS programs and provide an assessment of the possible resulting business impact.
- Build strong networks and work with teams in other ResMed locations to ensure that Quality Assurance systems/processes are in alignment Globally.
- Support the audit program (Internal, Supplier and External) to meet the requirements of the business and applicable external regulatory bodies.
Other
- Strong listening, verbal and written communication skills.
- Ability to identify linkages and dependencies between processes.
- Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
- Ability to successfully influence others to achieve outcomes.
- Bachelor’s degree in science or engineering.
