Working closely with the Director of Engineering and Project Director, the Quality Manager will be responsible for maintaining neo-bionica's quality performance through the effective implementation, maintenance and continual improvement of the Quality Management System (QMS), ensuring efficient and compliant application of QMS requirements across new and existing client development projects, manufacturing activities and business operations. This is a hands-on role requiring a proactive individual who takes ownership of quality management activities, ensures compliance with ISO ***** and applicable regulatory requirements, and works collaboratively with project, engineering, manufacturing and operational teams. The Quality Manager will report to neo-bionica's CEO. This position is in office, part-time at 0.6 FTE, with the salary calculated pro-rata.
Key responsibilities
Create, maintain, and improve Qualio templates in line with business needs and QMS requirements
Guide document owners in creating, updating, reviewing and approving relevant documentation
Maintain document and record control, including hardcopy quality records, revision control for projects, documentation and materials, and applicable regulatory record requirements
Create and maintain training plans, provide QMS training as required, and conduct quality inductions for new staff members
Review and approve materials, equipment, service activities, device assembly records and batch records
Conduct supplier assessments, maintain the approved supplier list, and perform site and supplier audits as required




Participate in risk management activities and support establishment and maintenance of risk management files
Drive nonconformance investigations with the NC owner and own or action audit finding NCs and corrective and preventive actions
Collate quality metrics for input into management review meetings
Manage and participate in internal and external audits, including hosting external audits where required
About you
Experience working in a certified ISO ***** environment
Thorough knowledge of ISO ***** and FDA 21 CFR Part 820
Experience administering or maintaining an electronic QMS, preferably Qualio
Strong attention to detail and excellent documentation skills
Ability to contribute at both strategic/management and hands-on execution levels
Team player with excellent interpersonal and communication skills
Understanding of medical device development and regulatory pathways (preferred)
Knowledge of manufacturing establishment (preferred)
Knowledge of EN ******* and ISO ***** standards (preferred)
Experience with design and/or manufacturing of class III implantable medical devices (preferred)
Minimum 5 years' experience
About us
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.
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📌 Quality Manager (Melbourne)
🏢 NEO-BIONICA
📍 Melbourne