Quality Control Assistant

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti‑calcification technology, is designed to mimic the natural function of a healthy heart valve. The Quality Control (QC) Assistant supports the manufacture of medical devices by performing a wide range of quality and material control activities. These include disinfection of reusable items, material release inspections, dispatch of test samples, handling garments and mops, inspection of packaged product, environmental monitoring, and preparing materials for production staging. This is a highly visible, hands‑on, and collaborative role that makes a meaningful contribution to our organisation’s success. Key Responsibilities Quality Control Disinfect reusable materials using washer–disinfectors. Execute autoclave cycles and routine autoclave maintenance (vacuum leak tests, Bowie–Dick testing). Release reusable material following autoclave processing. Perform material release in accordance with Starting Material Specifications (SMSs). Receive incoming tissue deliveries for use in the manufacture of biological medical devices. Inspect packaged product following Acceptance Quality Level (AQL) procedures. Conduct environmental monitoring (EM) in a cleanroom environment and perform associated microbiological plate reading. Monitor and clean controlled equipment (e.g., refrigerators, freezers). Participate in departmental and organisational meetings as required. Material Handling Pass materials through to production in line with stock requests. Assist with labelling and storing released materials. Manage the receipt and dispatch of garments and mops. Safely operate walkie‑stackers, pallet jacks, and other material‑handling equipment. Serve as back‑up for the Material Coordinator as required. Inventory Management Assist with regular cycle counts and physical inventory checks. Follow FEFO (First Expired, First Out) principles for materials with defined shelf lives. Ensure materials are stored, labelled, and organised to maintain full traceability of batch/lot numbers and expiry dates. Partner with the Quality team to ensure all materials meet required standards before use in production. Support the production team by providing materials in a timely and organised manner. Transfer finished product between quarantine and approved storage areas. Provide back‑up support for the Material Coordinator as needed. Documentation & Compliance Follow established procedures for disinfection, material release, EM, and AQL in compliance with ISO 13485 and relevant regulatory requirements. Complete all documentation accurately, including disinfection cycle records, EM results, incoming tissue receipt forms, and SMS documentation. Work with the Quality team to quarantine non‑conforming materials, ensuring they are not released until formally approved, and raise deviations in accordance with site SOPs. Continuous Improvement Review, revise, and create SMSs, procedures, and related documents as required. Initiate and participate in change control processes. Identify opportunities to improve efficiency and eliminate non‑value‑added activities across material handling and quality control processes. Training Undertake all required training to perform responsibilities effectively. Complete GMP training at least annually. Perform trainer duties when qualified. Qualifications & Skills Knowledge of general laboratory practices. Understanding of GMP and relevant regulatory requirements (desirable). Experience working in small, multi‑disciplinary teams (desirable). Proficiency with Microsoft Office software. Strong communication and interpersonal skills. Accurate record‑keeping abilities and high attention to detail. Note: We may require proof of COVID‑19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations. Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturalism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale. #J-18808-Ljbffr