About the company
This global blue chip business has a name that is synonymous with the pharmaceutical industry - an instantly recognisable brand, they have a large and well established network in Australia, developing and producing products that improve the lives of patients in their time of need. This underpins the mission of their business and drives their people to create the best possible outcomes for their stakeholders. Their physical operations are undergoing a period of growth which has included a range of new products being integrated to their local manufacturing footprint, and in turn this as seen the realisation of new roles such as this one.
About the role
This is a critical role on a highly important medical devices product integration project currently in the design stage. You will provide high level technical QA advice to the project team and to stakeholders ranging from the project team through to senior business leadership both local and international. As an experienced medical devices QA practitioner, you will lead the company with regard to QA and compliance requirements of medical devices products in the Australian market and their manufacture. As the project unfolds, you will work closely with stakeholders as a subject matter expert ensuring that new equipment and processes will meet or exceed standards, and that QA systems and programs are scoped and implemented appropriately.
We're looking for someone who is an experienced medical devices QA practitioner
- Relevant tertiary degree, likely science, engineering or similar
- Proven QA experience in the medical devices manufacturing
- Strong understanding of TGA, EU MDR and FDA regulatory particularly around medical devices
- Broad understanding of cGMP requirements including equipment validation for clean room environment
- Experience scoping and implementing QA programs to support new products
- Ability to proactively handle challenging deadlines, act with sense of urgency and be an excellent communicator
This is an exciting opportunity because it has a lead role on a critical project - this is a real opportunity to play a key role, and to bring unique expertise in medical devices to a business that would highly value it. Despite this being a 24 month contract role initially, with your unique experience you would be a likely candidate for ongoing opportunities beyond the initial contract period. This role is also a fantastic move towards a QA Manager position, giving you critical leading experience and allowing you to demonstrate your engagement and influencing skills to set you up for that next step. Further, you will add pharmaceutical experience to your arsenal, which is a rare combination.
How to apply
Click on the APPLY button or contact Scott Logan for a confidential discussion on 03 8613 3551