Quality Assurance Associate
Vor 7 Tagen
Proclinical are proud to be partnered with our client, a long-established Australian medical device manufacturer recognised globally for its leadership in cardiac stimulation solutions used in electrophysiology labs worldwide. Our client designs and manufactures specialised cardiac pacing systems distributed internationally through partnerships with major healthcare multinationals. Their operations run under stringent global regulatory frameworks including ISO 13485 , MDR , FDA , and TGA . Role Overview Reporting to the QA Manager , the Quality Assurance Associate will play a key role in ensuring operations , documentation , and product lifecycle activities comply with internal quality processes and international regulatory expectations . This position suits someone with strong attention to detail, a proactive mindset, and at least one year of experience in a biomedical, medical device, or similarly regulated industry. Start: ASAPLocation: Onsite (Homebush West)Employment Type: Full-time, permanentWork Rights: Full Australian work rights required Key Responsibilities Lead and support Change Control activities. Maintain and manage the company’s document control processes. Act as a key contact for quality issues , NCs , and CAPAs , ensuring timely resolution and documentation. Maintain and update the company's product configuration files . Prepare supplier assessment reports ; support QA Manager with supplier controls and monitoring. Collaborate with engineering teams to update and maintain compliance with engineering work instructions . Support the QA Manager in maintaining up-to-date quality work instructions . Assist in preparing quality KPI reports and support trend analysis. Contribute to internal and external audits (TGA, notified bodies, suppliers). Maintain the company’s standards and regulations library to ensure ongoing compliance. About You You are curious, meticulous, and intellectually engaged. You enjoy solving problems, thrive in structured environments, and are eager to build your career in medical device quality. You work well with cross‑functional teams and take pride in producing error‑free, compliant work. Skills & Experience Must‑haves Minimum 1 year experience in a Quality Assurance, Document Control, or similar role—ideally in medical devices or another highly regulated industry. Tertiary qualification in Science, Biomedical Engineering, or related discipline . Strong time management and organisational skills. Clear and effective communication skills; ability to liaise with engineering, production, and leadership teams. Fastidious attention to detail and accuracy. Proficient in Microsoft Office (Word, Excel, PowerPoint). Self‑motivated, proactive, and open to feedback with a growth mindset. Nice‑to‑haves Understanding of ISO 13485, ISO 14971, EU MDR, FDA QSR, or TGA requirements. Experience supporting internal or external audits. Technical writing or documentation structuring experience. How to Apply If this opportunity aligns with your experience and career goals, please click Apply Now to submit your application. For a confidential discussion or to learn more, please contact Pamela Phoumavong at ************@proclinical.com or *** . #J-18808-Ljbffr
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