QArc Associate

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. Our vision is to advance cancer diagnostics and improve lives

This position is part of the QARC team located in Melbourne and will be on-site at Leica Biosystems.

You will be a part of the QARC team and report to the Manager, Regulatory Compliance responsible for both regulatory and quality duties as assigned. If you thrive in a fast-paced, supporting role and want to work to build a world-class organization—read on.

**In this role, you will have the opportunity to**:

- Follow relevant regulations related to products of Leica Biosystems.
- Process customer complaints as per global and local procedures under the supervision of senior team members until deemed competent to carry such activities independently.
- Work closely with senior team members in performing post market surveillance and adverse event reporting for IVD products per global and local regulatory expectations.
- Participate in daily management meetings for awareness and present data relevant to their work as required
- Follow quality procedures and standards for Leica Biosystems.
- Provide necessary support in the CAPA process for issues related to complaints/adverse events and field actions.

**The essential requirements of the job include**:

- Bachelor's degree or equivalent advanced degree in engineering, science, medical, or technical field and 3+ years' experience.
- Minimum 3 years of experience in quality assurance and/or regulatory affairs
- Good understanding of Medical Device/IVD regulations and ISO 13485

**Travel, Motor Vehicle Record & Physical/Environment Requirements**:
Travel expectations for this role are low (