Associate, Quality Assurance/regulatory Compliance

2 weeks 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.

This position is part of the Regulatory Compliance / Quality Assurance department located in Mt Waverley, Melbourne, and is an on-site position and 12 month fixed term. You will be a part of the Regulatory Compliance team, reporting to the Regulatory Compliance Manager, sharing responsibilities for the site’s compliance with its quality management system and regulatory requirements.

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

- Be responsible for planning, organizing and conducting duties related to assigned element of the site quality system. This may include one or more of the following areas:

- Quality Systems
- Maintain quality system to meet all applicable requirements for medical device/IVD business, e.g. 21 CFR 820 and ISO 13485
- Audits
- Non conformances
- CAPA
- Change Control process
- Batch release
- Training
- Quality agreements
- Record management and document control
- Premarket QA / Design Assurance / R&D Quality
- Support as QA representative for Design Controls and Risk Management for new product development projects and device change initiatives
- Support design quality assurance for cross-site project
- Establish and maintain strong relationships with internal and external stakeholders.
- Perform regulatory tasks as assigned such as but not limited to Product Registrations, Developing and maintaining technical documentation, Change assessments, Labelling review etc.
- Assist senior regulatory team members in day-to-day regulatory activities as required

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

- Bachelor’s degree in science, medical or technical field, or suitable equivalent
- Demonstrable high level of attention to detail is essential.
- Self-starter with a strong desire to drive projects and tasks to completion.
- Ability to detect problems and analyze data.
- Strong organizational skills. Ability to multitask.
- Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports

**It would be a plus if you also possess previous experience in**:

- The Quality or Engineering departments of Medical Device, IVD or Manufacturing environments

**Travel** %_ of Travel, include approximate overnight stays per week_
- Travel expectations for this role are low (

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