Senior Quality Associate

4 weeks ago

Adelaide, South Australia Fertilis Pty Ltd Full time

$90,000 – $100,000 per year (negotiable)

Fertilis, founded by IVF change-agents Prof. Jeremy Thompson and Prof. David Gardner, is reimagining IVF with world-first micro-medical technologies that will transform fertility treatments.

We are a fast-growing startup with global ambitions - and we're looking for a Senior Quality Associate who wants to grow with us.

Ideally based in Adelaide (our HQ), we are also open to candidates in other locations across Australia, with flexibility for the right person.

In this role, you'll take ownership of our Quality Management System, support our regulatory pathway to FDA and MDR approvals, and partner with our scientists, engineers, and operations to ensure our devices are safe, compliant, and ready for global markets. You'll work hands-on with our team, external partners, and regulators, developing skills that will prepare you to step into a future Quality Manager role.

What you'll do:

Lead QMS operations as the Management Representative - Maintain, improve, and embed our quality system to support a regulated medical device business.

Support regulatory pathways - Work with our regulatory specialists to prepare documentation for FDA, MDR, and TGA approval.

Enable product launch - Partner with product development and production to ensure design control and compliance are built in from day one.

Navigate stakeholders - Build strong working relationships across regulators, suppliers, and auditors.

Grow with us - Step outside your comfort zone and expand your skills toward a leadership pathway.

About you:

3+ years' experience in medical devices, pharma, or life sciences quality/regulatory roles.

Strong understanding of ISO 13485 and global regulatory environments.

Detail-oriented, proactive, and comfortable working in a fast-moving startup.

Willingness to grow and take on broader responsibilities as the company scales.

This is your chance to be at the ground floor of the most exciting change in IVF in 35 years - and to help bring life-changing technologies to patients worldwide.

Apply now and grow with Fertilis.

Unlock job insights

Salary match Number of applicants Skills match

Your application will include the following questions:Which of the following statements best describes your right to work in Australia? How many years' experience do you have as a Quality Associate? Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)? How much notice are you required to give your current employer?

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