Quality Management Systems Specialist – Medical Devices

About the Role

We are seeking an experienced Quality Management Systems Specialist to join our team and play a key role in the redevelopment of our Quality Management System (QMS).

This is a hands-on role for someone with practical knowledge of ISO 13485 who enjoys developing processes, solving problems and turning quality and regulatory requirements into clear, workable procedures.

Working closely with management and process owners across the business, you will help review existing practices, identify opportunities for improvement, and develop and document processes that support an effective and compliant QMS.

This is more than a technical writing role. We are looking for someone who can understand a process, ask the right questions, consider the relevant requirements and help develop practical ways of working.

What You'll Be Doing

• Supporting the redevelopment and implementation of our QMS

• Working with process owners to review, develop and document processes

• Creating and improving procedures, work instructions, forms and other QMS documentation

• Helping ensure our QMS aligns with ISO 13485 and applicable TGA and FDA requirements

• Identifying gaps and recommending practical improvements

• Supporting key quality activities such as document control, CAPA, change control, risk management, training and auditing

• Assisting with the implementation of new and revised processes across the business

About You

We're looking for someone with:

• Practical experience with ISO 13485 and medical device quality management systems

• Experience developing, improving or documenting QMS processes and procedures

• Strong written communication and attention to detail

• The ability to work independently while collaborating with people across different areas of the business

• A practical, solutions-focused approach to quality management

Experience with TGA and/or FDA medical device requirements, regulatory audits or QMS redevelopment projects would be highly regarded.

Most importantly, we're looking for someone who understands quality management systems and can work with our team to turn requirements into processes that make sense in practice.

The Opportunity

This is an opportunity to have a meaningful role in the redevelopment of an established Australian medical device company's QMS and contribute to how processes are developed and implemented across the organisation.

The position is offered on a 12-month fixed-term basis. While there may be an opportunity for further employment depending on business requirements at the completion of the fixed term, this is not guaranteed.

The role is based at our Jandakot, Western Australia premises, requires an on-site presence and is available for an immediate start.

If you have experience with ISO 13485 and believe your skills could be a good fit, we encourage you to apply even if you don't meet every point listed above.

Please submit your resume together with a brief cover letter outlining your relevant experience.