Quality Control Associate

Join to apply for the Quality Control Associate role at Anteris Technologies . 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-calification technology, is designed to mimic the natural function of a healthy heart valve. The Quality Control (QC) Associate plays a vital role in supporting the Anteris Malaga sites’ manufacturing operations by ensuring all QC activities — including environmental monitoring, product testing, and visual inspection — are performed accurately and on schedule. This role works closely with the Quality team to implement, maintain, and operate quality control systems and processes across the facility, contributing directly to the reliable production of high-quality medical devices. Key Responsibilities Accountability Perform visual inspection inside a controlled cleanroom area on manufactured product to disposition it as pass or fail. Execute routine duties to ensure the cleanliness and operational status of equipment used for manufacturing of finished product at the Malaga site. Undertake environmental monitoring duties such as performing the monitoring and plate reading to ensure clean room standards and cleaning effectiveness are being maintained. Perform investigation of environmental monitoring excursions. Manage and liaise with approved third‑party contract testing laboratories for external microbiological testing such as for growth promotion testing of environmental monitoring plates, identification of micro‑organisms, in process and finished product testing. Perform microbiological and analytical quality testing tasks: visual inspection, crosslink stability testing, pH testing, endotoxin testing and gas chromatography. Perform inspection tasks: AQL inspection of packaged finished product and final product visual inspection. Participate in validation work, continuous improvement projects, or implementation of new processes or systems as required. Update data used for metrics related to QC department operation in order to identify trends, risks and opportunities for improvement as required. Review, revise and create procedures and documents as required. Ensure compliance with site SOPs and GMP. As required, raise deviations, and investigate accordingly. Participate in change control and CAPA as required. Participate and respond to internal and external audits relating to Quality Control. Participate in cross‑training of duties as required. Reporting Updating QC databases for Quality metrics for Site Review Meetings. Provide data for annual reviews for microbial quality (e.g., Environmental Monitoring and in‑process Bioburden). Assisting with validation protocols and reports as required. Training Complete GMP training at least once annually. Complete all required training for assigned duties. Ensure all training documentation is maintained and updated. Cross‑train in other Quality duties to provide assistance as required. Qualifications & Skills Bachelor of Science qualifications in biological or medical science (or equivalent). Understanding of quality systems in medical manufacturing, including an understanding of ISO13485 and 21 CFR 820. Experience in the control and monitoring of GMP medical manufacturing environments and products. Sound knowledge of general laboratory practices. Prior experience working in small multi‑disciplinary teams. Proficient in the use of Microsoft computer software (e.g., MS Office). Sound communication and interpersonal skills. Administrative competencies and attention to detail. Ability to work in laboratory and cleanroom settings where PPE and special gowning requirements are essential. 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