Senior Quality Assurance Engineer - Audits
Excellent opportunity to join ResMed who provide innovative products that improve the lives of millions of people with sleep and respiratory disorders
Summary about this job
Quality Assurance & Control
Company: ResMed
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-7-3721-6715
Fax: +61-2-4943-5893
E-mail: n\a
Site: n\a
Detail information about job Senior Quality Assurance Engineer - Audits. Terms and conditions vacancy
Senior / Quality Assurance Engineer - Audits
Why ResMed?
Imagine what you could accomplish if you could drive positive change every single day. At ResMed, you can find out. As a world-leading connected health company with more than 4 million cloud-connected devices, our work changes lives with every breath. Our award-winning devices and software solutions help treat and manage sleep apnoea, chronic obstructive pulmonary disease and other respiratory conditions.
We are currently seeking applications for a Senior Quality Assurance Engineer - Audits to join our Quality Assurance team based at Bella Vista, Sydney.
Let’s talk about this position:
The Senior Quality Assurance Engineer will help ensure that ResMed’s products and the design and manufacturing operations comply with regulatory requirements such as, but not limited to, Food and Drug Administration FDA in the US, relevant competent authorities in Europe, and the Therapeutic Goods Administration (TGA) in Australia, ISO 13485 and MDSAP.
The successful candidate will be performing the responsibilities, but not limited to, as below:
Coordinate the planning, conduct, reporting and resolution of issues associated with the quality and environmental audit programs
Fostering quality and environmental culture
Ensuring ongoing audit readiness across the business
Prepare and implement a comprehensive internal and supplier audit program
Project manage the activities resulting from observations and non-conformances raised during internal audits by liaising with stakeholders and drive these findings to effective and timely closure
Support and represent ResMed in external audit situations
Recommend opportunities for continuous improvement of the audit system
Let’s talk about you:
You will have internal and external audit experience and be knowledgeable of FDA and TGA regulatory requirements and experience in applicable international standards such as ISO 13485.
To get us really excited, you will have a Bachelor Degree in Engineering or Science with formal training in Quality Systems audits and 5 + years audit experience.
Candidates who have a Lead Auditor Certification, are able to interpret technical requirements, have knowledge of process validation and prior experience as a Manufacturing or Process Engineer.
OK, so what next?
At ResMed, we believe in supporting, inspiring and developing our people. So we recruit the best and then give them the tools to make a real difference in the lives of our patients. We believe that fresh thinking inspires innovation - and our shared success. If this sounds like a place you would like to work and you have the drive to transform and enhance the lives of millions of patients through your contribution at work, then today is your day! Apply now!