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.The Officer QARC, for Leica Biosystems is experienced in multiple areas of medical device quality assurance and regulatory affairs and can apply that experience and in-depth knowledge to work independently with minimal guidance from management, serving as a resource for colleagues with less experience.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 SystemsMaintain quality system to meet all applicable requirements for medical device/IVD business, e.g.
21 CFR 820 and ISO 13485AuditsNon conformancesCAPAChange Control processBatch releaseTrainingQuality agreementsRecord management and document controlPremarket QA / Design Assurance / R&D QualitySupport as QA representative for Design Controls and Risk Management for new product development projects and device change initiativesSupport design quality assurance for cross-site projectEstablish 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 equivalentDemonstrable 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: Travel expectations for this role are low.#J-18808-Ljbffr