Quality Control (Qc) Assistant At Anteris Technologies (Perth)

Quality Control (Qc) Assistant At Anteris Technologies (Perth)

15 Aug
|
Anteris Technologies
|
Perth

15 Aug

Anteris Technologies

Perth

Apply for Quality Control (QC) Assistant at Anteris Technologies in Perth, WA, AU.
This full‐time on‐site position offers great opportunities for growth opportunities.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.Key ResponsibilitiesQuality Control – Disinfection of reusable material using washer disinfectorsExecuting autoclave cycles & autoclave maintenance (vacuum leak test, B&D; testing)Release of reusable material post‐autoclave and disinfectionPerform release of material using starting material specifications (SMS's)Receipt of incoming tissue deliveries for use in the manufacture of a biological medical deviceInspection of packaged product using acceptance quality level (AQL) proceduresPerform environmental monitoring (EM)



in a clean room setting and execute associated microbiological plate readingMonitoring and cleaning of equipment (refrigerators, freezers)Attend departmental and organisational meetings as requiredMaterial HandlingAccurately pick and pass‐through materials for production according to stock requestsLabel released material and store appropriatelyAssist with packing product shipments according to work ordersReceipt and dispatch of garments and mopsOperate walkie‐stacker, pallet jacks, and other material‐handling equipment safely and efficientlyBack‐up for the Material Coordinator as requiredInventory ManagementAssist with the conduct of regular cycle counts and physical inventory checksFollow FEFO (First Expired, First Out) principles for materials with shelf livesEnsure materials are properly stored, labelled, and organised to maintain traceability of batch/lot numbers and expiration datesWork closely with the Quality team to ensure materials meet quality standards before use in productionWork closely with the production team to provide materials needed for manufacturing in a timely mannerTransfer of final product between quarantine and releaseDocumentation and ComplianceFollow established procedures for disinfection, material release, EM, and AQL in compliance with ISO ***** and FDA regulationsComplete all required documentation accurately, including disinfection cycle records, EM records, incoming tissue receipt forms and Starting Material Specification (SMS) formsPrepare documentation for audits, inspections, and quality checks, ensuring full traceabilityWork 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 SOPsLogisticsEnsure adequate materials are supplied to pericardial supplier(s) to ensure harvest,



processing and delivery of materials can occur according to agreed schedulesWork with Quality to arrange packing and dispatch of samples for testingAssist with the preparation of temperature‐controlled shippers for use in dispatching product including programming of temperature loggersContinuous ImprovementReview, revise and create SMSs, procedures and related documents as requiredInitiate and participate in change control as requiredSeek to find efficiencies and to remove non‐value‐added time and activity from materials handling and quality control processesTrainingUndertake appropriate training as required to effectively perform your roleComplete GMP training at least once annuallyPerform trainer dutiesSkills, Knowledge, Experience & QualificationsKnowledge of general laboratory practicesUnderstanding of GMP and relevant regulatory requirements (desirable)Prior experience working in small multi‐disciplinary teams (desirable)Proficient in the use of Microsoft computer software (e.g., MS Office)Sound communication and interpersonal skillsAccurate record‐keeping skills, attention to detail, and general administrative competenciesAbility to work in laboratory and cleanroom settings where PPE and special gowning is requiredWhat We OfferOpportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapiesCollaborative and dynamic work environment with a culture of innovation and excellenceCompetitive compensation packageCareer development opportunities and a chance to be part of a growing company that values its employeesNote: 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.
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📌 Quality Control (Qc) Assistant At Anteris Technologies (Perth)
🏢 Anteris Technologies
📍 Perth

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