Quality Manager

Neo-Bionica Pty Ltd; City of Melbourne; On-site; AUD 90,000 - 120,000; Part time

Job summary

neo-bionica is seeking a Quality Manager to maintain quality performance through the effective implementation, maintenance and continual improvement of the QMS across client development projects, manufacturing activities and business operations.

This hands-on role requires ownership of quality management activities, ensuring ISO 13485 compliance and applicable regulatory requirements, and collaboration with project, engineering, manufacturing and operations teams.

Qualifications

• Experience in a certified ISO 13485 environment.
• Strong knowledge of ISO 13485 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 45502-1 and ISO 14971 standards (preferred).
• Experience with design and/or manufacturing of class III implantable medical devices (preferred).
• Minimum 5 years' experience

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

Skills

ISO 13485

QMS management

Regulatory knowledge

Documentation & records

Audits

Risk management

Medical device manufacturing

Team player

Qualio

Proactive

Tools

Qualio

Job description

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 13485 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 on-site, 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 13485 environment
• Thorough knowledge of ISO 13485 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 45502-1 and ISO 14971 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.