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Officer, Quality Assurance and Regulatory Compliance

1 month ago

Mount Waverley, Australia Leica Biosystems Full time

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.

The **Officer, Quality Assurance and Regulatory Compliance** for Leica Biosystems is responsible for ensuring the site remains compliant with its applicable Quality Management System and regulatory requirements.

This position is part of the Quality Assurance and Regulatory Compliance (QARC) department located in Mount Waverley, Melbourne, and will be on-site.

You will be reporting to the Regulatory Compliance Manager responsible for performing shared duties across quality and regulatory functions. 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**:

- Plan, organize and conduct duties related to the assigned element of the site quality system such as maintaining compliance of the QMS with 21CFR 820 and ISO 13485 requirements.
- Participate in, and where required conduct internal audits
- Handle process and product-related non-conformances
- Conduct and/or participate in the CAPA process
- Perform/participate in validation activities as required
- Be involved in batch release of instruments, document control, and record management
- Assist the regulatory team in performing various regulatory tasks such as product registrations, change assessments, gap assessments, documentation review etc.

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

- Bachelor’s degree, ideally in science, medical or technical field
- Minimum of 2 years of Quality Assurance experience in the MD/IVD industry
- Good understanding of Medical Device/In-Vitro Diagnostic Device Regulations, especially MDSAP countries
- Experience working in a team environment
- Continuous improvement mindset and understanding of tools such as 5why's/fishbone/ Kaizen/ Daily management/ process mapping.
- High level of attention to detail, with sound analytical and problem-solving skills
- Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, and reports.

**Travel Requirements**:

- Travel expectations for this role are low (