The primary role of the Quality Assurance, Quality Systems function is to ensure that management systems are established to enable business compliance to multiple regulatory frameworks, and to support the design, development, manufacture, and service of products which meet our customer’s quality requirements.
The Quality Assurance - Quality Systems function supports:
The management, maintenance, and optimisation of the structure and integrity of the Quality Management Systems (QMS) to ensure ResMed’s products and processes comply with the regulatory requirements applicable to medical devices for the markets in which they are distributed.
Let’s talk about Responsibilities
The Quality System Specialist will help the business by performing a variety of actions supporting ResMed locations Globally and QMS processes broadly, including, but not limited to:
Quality System data reporting
- Regular review and collation of Quality data from multiple quality systems and processes for timely reporting of quality system performance to management, including, but not limited to: CAPA performance, Training compliance, Audit action monitoring and process adherence, change notes various, supplier management and monitoring.
- As required, taking on actions determined from data reporting to address issues and implement continuous improvement activities.
Document and Records Management
- Supporting management and maintenance of the relevant business systems (e.g., Objective, Oracle, SmartSheet, Tableau) and processes by:
- assessing changes to ensure adequacy and completeness.
- implementing changes in the relevant systems
- supporting ongoing maintenance and improvements to the systems and processes.
Training
- Providing training compliance reports as required, performing impact assessments, and documenting requested changes to training assignments
- Support the creation and maintenance of training materials.
Audit
- As needed, supporting preparation for, and conduct of, internal and supplier audits together with monitoring of elements of the Global Audit Program (internal, supplier and external)
Corrective Action and Preventive Action (CAPA)
- Providing support to ensure timely preparation and reporting of CAPA and compliant CAPA records and preparing relevant metrics.
Supplier Management and monitoring:
- Supporting Supplier maintenance activities, including evaluations, monitoring and associated record management within ResMed business systems.
- Undertake and support other QA ad hoc activities as required.
Let’s talk about Qualifications and Experience
Required:
- Bachelor’s degree in Science or Engineering
- Experience of ISO 13485 and/or 21 CFR Part 820 requirements.
- Minimum 2 years applied professional quality assurance experience ideally including the medical device, pharmaceutical, or other regulated industry.
- Strong listening, verbal, and written communication skills.
- Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
- Agility to adapt and respond quickly while being resilient to overcome obstacles, escalating issues as necessary.
- Ability to work as part of a broader Global Team, including across time zones.
- Possess a strong attention to detail and be highly organized.
Preferred:
- ERP/Oracle experience
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!
What We Do
ResMed provides medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders.
