Job Information
Danaher Corporation Officer, Quality Assurance and Regulatory Compliance in Mount Waverley, Australia
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 (<10%)
It would be a plus if you also possess previous experience in:
Project management
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.