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 Responsibilities

- Quality Control – 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 the 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 the conduct of 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 organised 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 and Compliance

- Follow established procedures for disinfection, material release, EM, and AQL in compliance with ISO 13485 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 pericardial 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 SMSs, 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

Skills, Knowledge, Experience & Qualifications

- Knowledge of general laboratory practices
- Understanding 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 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 environment 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.

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📌 Quality Control (QC) Assistant at Anteris Technologies (Perth)
🏢 Anteris Technologies
📍 Perth