Quality Engineer

Organisation: 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·      Guides document owners in creating, updating and approving relevant documentation·      Creates and maintains training plans and provides training as required by the QMS·      Conducts quality inductions for new staff members·      Reviews and approves materials, equipment and service activities·      Conducts supplier assessments and maintains the approved supplier list·      Participates in risk management activities and establishes the risk management file·      Participates in project and team meetings as a value adding participant·      Maintains hardcopy quality records per regulatory requirements·      Oversees revision control for projects, documentation and materials·      Reviews and approves device assembly and batch records·      Drives nonconformance (NC) investigations with the NC owner·      Collates quality metrics for input into the management review meetings·      Participates in internal and external audits·      Owns and actions audit finding NCs and corrective and preventive actions.·      Supports lean manufacturing and operational activities within the organisation.Core Competencies:Essential:·      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·      Excellent documentation skillsDesirable:·      Knowledge of medical device regulatory pathway·      Experience with design and/or manufacturing of class III implantable medical devices·      Strong technical and problem-solving skills