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Quality Engineer

vor 4 Wochen


City of Melbourne, Österreich neo-bionica Vollzeit

neo-bionica is a pioneering product development and contract manufacturing company specialising in neurotechnology, headquartered in Australia. Our mission is to partner in developing cutting‑edge medical devices that improve the quality of life for individuals with neurological conditions. We are committed to innovation, excellence, and transforming healthcare through advanced technology. Position Summary The Quality Engineer is responsible for ensuring that the quality management system (QMS) is implemented and effective at neo-bionica. The Quality Engineer works within the Quality team and contributes to the efficient and compliant running of the QMS. This position is an on‑site, 0.6 FTE position. Key Responsibilities Oversee the validated state of Qualio, the neo-bionica electronic QMS Create and maintain Qualio templates as per the business needs Guide document owners in creating, updating and approving relevant documentation Create and maintain training plans and provide training as required by the QMS Conduct quality inductions for new staff members Review and approve materials, equipment and service activities Conduct supplier assessments and maintain the approved supplier list Participate in risk management activities and establish the risk management file Participate in project and team meetings as a value adding participant Maintain hardcopy quality records per regulatory requirements Oversee revision control for projects, documentation and materials Review and approve device assembly and batch records Drive nonconformance (NC) investigations with the NC owner Collate quality metrics for input into the management review meetings Participate in internal and external audits Own and action audit finding NCs and corrective and preventive actions Support lean manufacturing and operational activities within the organisation Core Competencies Minimum of 3 years’ experience working in a quality role in a regulated environment such as medical devices, pharmaceuticals or biological products Thorough knowledge of ISO 13485 and ISO 14971 Knowledge of medical device regulatory pathway Experience with design and/or manufacturing of class III implantable medical devices Strong technical and problem‑solving skills Seniority level Mid‑Senior level Employment type Part‑time Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at neo-bionica by 2x. Get notified about new Quality Engineer jobs in Melbourne, Victoria, Australia. #J-18808-Ljbffr