Quality Assurance Specialist

vor 3 Wochen

Council of the City of Sydney, Österreich i-Pharm Consulting Vollzeit

Senior Quality Assurance Specialist (12-month Maternity Leave Cover) Sydney | Hybrid (4 days office, 1 WFH) | $50 - $60 per hour Are you a Quality professional ready to take ownership and make an impact in a collaborative, supportive team? This is a fantastic 12‑month opportunity to join a global medical technology leader as a Senior Quality Assurance Specialist, covering a maternity leave period - starting mid‑January You’ll be part of a small, hands‑on quality team that partners closely across regulatory affairs, marketing, sales, and global colleagues. The environment is inclusive and flexible, where initiative and a willingness to learn are genuinely valued. This role will be suitable for an experienced quality assurance professional from medical devices, pharma, cro or similar. Senior Quality Assurance Specialist Quality Assurance Specialist Quality Assurance Associate What you’ll be doing Supporting day‑to‑day quality activities, including post‑market surveillance and adverse event reporting. Managing CAPA processes, problem‑solving using structured quality methodologies. Assisting with document control, training management, and protocol development. Preparing and translating quality reports for submission to ANZ authorities. Collaborating across departments to ensure compliance, continuous improvement, and system integrity. What we’re looking for Prior experience in Quality Assurance—ideally within medical devices, diagnostics, or pharmaceuticals. Knowledge of CAPA, document control, supplier management, and quality systems. Exposure to ISO 9001:2015 or ISO 13485 standards and auditing (internal or external). Strong attention to detail and a proactive approach to learning and improvement. Excellent communication skills and the ability to manage both independent tasks and cross‑functional collaboration. Systems you’ll use SBN (for CAPA and supplier management) M/files (document control) ISOtrain Why you’ll love it here Hybrid working model – choose your WFH day Free onsite parking, on‑site gym, and café with a barista Supportive team culture with direct access to APAC leadership Structured handover and onboarding (2.5–3 weeks) Opportunity to own key quality processes and broaden your experience in other areas Next steps Interviews will be a single‑stage discussion with the Quality Manager, focusing on practical experience and approach to problem‑solving. #J-18808-Ljbffr

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