Apply for Quality Control (QC) Assistant at Anteris Technologies in Malaga, WA, AU. This full‐time on‐site position offers great opportunities for career growth. 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. Reporting to the Director of Quality, the Disinfection & Quality Control (QC) Assistant supports the manufacture of medical devices by performing quality and material control activities such as disinfection of reusable items, material release inspection, dispatch of test samples, receipt and dispatch of garments and mops, inspection of packaged product, environmental monitoring plus cleaning of material for production staging. This is a highly visible and supportive role, making a positive contribution to our organization's success. At Anteris® Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.
Key Responsibilities
Disinfection & QC
Disinfection of reusable material using washer disinfectors
Executing autoclave cycles & autoclave maintenance (vacuum leak test, B&D; testing)
Release of reusable material post‐autoclave and disinfection
Perform release of material using starting material specifications (SMS's)
Receipt of incoming tissue deliveries for use in manufacture of a biological medical device
Inspection of packaged product using acceptance quality level (AQL) procedures




Perform environmental monitoring (EM) in a clean room setting and execute associated microbiological plate reading
Monitoring and cleaning of equipment (refrigerators, freezers)
Attend departmental and organisational meetings as required
Material Handling
Accurately pick and pass‐through materials for production according to stock requests
Label released material and store appropriately
Assist with packing product shipments according to work orders
Receipt and dispatch of garments and mops
Operate walkie‐stacker, pallet jacks, and other material‐handling equipment safely and efficiently
Back‐up for the Material Coordinator as required
Inventory Management
Assist with conduct regular cycle counts and physical inventory checks
Follow FEFO (First Expired, First Out) principles for materials with shelf lives
Ensure materials are properly stored, labelled, and organized to maintain traceability of batch/lot numbers and expiration dates
Work closely with the Quality team to ensure materials meet quality standards before use in production
Work closely with the production team to provide materials needed for manufacturing in a timely manner
Transfer of final product between quarantine and release
Documentation & Compliance
Follow established procedures for disinfection, material release, EM, and AQL in compliance with ISO***** and FDA regulations
Complete all required documentation accurately, including disinfection cycle records, EM records, incoming tissue receipt forms and Starting Material Specification (SMS) forms
Prepare documentation for audits, inspections, and quality checks, ensuring full traceability
Work with the Quality team to quarantine non‐conforming materials and ensure they are not released for production until approved, raising deviations as required by site SOPs
Logistics
Ensure adequate materials are supplied to pericardia supplier(s) to ensure harvest,



processing and delivery of materials can occur according to agreed schedules
Work with Quality to arrange packing and dispatch of samples for testing
Assist with the preparation of temperature‐controlled shippers for use in dispatching product including programming of temperature loggers
Continuous Improvement
Review, revise and create SMS's, procedures and related documents as required
Initiate and participate in change control as required
Seek to find efficiencies and to remove non‐value‐added time and activity from materials handling and quality control processes
Training
Undertake appropriate training as required to effectively perform your role
Complete GMP training at least once annually
Perform trainer duties
Qualifications & Skills
Knowledge of general laboratory practices
Understanding of GMP and relevant regulatory requirements (desirable)
Prior experience working in small multi‐disciplinary teams (desirable)
Proficient in Microsoft computer software (e.g., MS Office)
Sound communication and interpersonal skills
Accurate record‐keeping skills, attention to detail, and general administrative competencies
Ability to work in laboratory and cleanroom settings where PPE and special gowning is required
What We Offer
Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Collaborative and dynamic work workplace with a culture of innovation and excellence.
Competitive compensation package.
Career development opportunities and a chance to be part of a growing company that values its employees.
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-*****-Ljbffr

📌 Quality Control (Qc) Assistant At Anteris Technologies (Western Australia)
🏢 Anteris Technologies
📍 Western Australia