Quality Specialist

**About us**

Seer is a Melbourne-based medtech company challenging the status quo of how healthcare is delivered. Through award-winning medical devices, mobile apps and software solutions combined with an extensive research and development program, we are shifting the patient center of care from the hospital to the home.

Our mission is to open up access to brain, heart, and respiratory monitoring that is traditionally only offered through hospitals. We do this by creating medical products and services that transition hospital-based diagnostic testing into the home setting.

We also recognise that healthcare doesn’t stop after testing. Research is at the heart of what we do at Seer, and we’ve been leading the field in understanding seizure cycles and developing a seizure risk forecaster that will change the lives of millions living with uncontrolled epilepsy.

When you join the Seer team, you become part of a tight-knit group driven by purposeful work to make a huge impact in the world.

The Quality Specialist role is a part of the Quality and Regulatory team, where our focus is to support and ensure compliance with QMS, international and Australian regulations and maintain certification.

**In this role, the role requirements include**:

- Support the Quality Lead in the maintenance of the Quality Management System (QMS) to ensure that it complies with all applicable standards and regulatory requirements for medical devices.
- Provide support to the Manufacturing team to ensure that the final product meets the required quality standards, develop manufacturing documentation, and manage any non-conformances that arise.
- Provide support to the Technology Team, Software and Hardware to manage design changes as part of the change control process.
- Participate in training programs
- Assist in management Equipment Maintenance and Calibration
- Contribute to process improvements including Software / Process Validation
- Participate in the Internal Audit program
- Engineering or science degree
- At least 2 years’ experience in a regulated environment, preferably in the medical devices / pharma industry.
- Experience in non-conformances and writing quality documentation that complies with the following standards in a development, manufacturing and post market environment;
- ISO13485:2016
- US Quality System Regulations 21CFR 820
- Challenge the status quo. If there’s a better way of getting something done, that’s how we want to do it.
- Contribute to the global impact our ground-breaking products and technologies are making.
- Be empowered and enabled to do your best work.
- Be treated with respect by your colleagues and peers.

**Your experience**:

- Good documentation practice skills
- Attention to detail
- Experience delivering training is desirable
- Internal Auditing qualification and experience desirable

**Why choose Seer?**

At Seer, we are doing purposeful work solving some of healthcare’s most pressing problems.

You will:
**A bit more about us**
- Ranked #8 on Deloitte’s Tech Fast 50 in 2020 (Australia’s list of fastest-growing technology companies).
- Three prestigious design awards across Australia and Europe for our wearable EEG/ECG device, Seer Sense®.
- We’ve been awarded over AU$2 million in government fund grants towards new product innovation, manufacturing, and research in the last two (2) years
- Awarded ‘Most Outstanding Patient Innovation’ for 2021 by the Australian Patients Association.
- Our products and technologies are listed on the Australian Register of Therapeutic Goods, have earned CE accreditation, and are currently being evaluated for FDA approval.