Quality Officer

About Lubdub Lubdub is a Perth-based medical technology company developing next-generation cardiac health devices, including its Electro, Bio and Echo product lines. Based at the Herdsman MedTech Innovation Hub, the team works closely with clinical and research partners to bring innovative cardiac monitoring technology from concept through to regulatory clearance and market. Lubdub is at an exciting growth stage, building out the quality and regulatory foundations needed to support multiple products moving toward clinical use.
What Lubdub Offers A collaborative, hybrid working environment based at the Herdsman MedTech Innovation Hub Osborne Park, WA. The hub provides opportunities to work alongside multiple medtech start-ups, providing a unique experience and access to a range of skills and mentors. Hands-on exposure across the full product lifecycle for at least four products, from design control through to regulatory submission The opportunity to build a career in medical device quality and regulatory affairs from the ground up, with genuine ownership and mentorship Opportunities for career advancement including 1:1 mentoring by supportive industry leaders and tailored development plan The chance to contribute to technology that improves cardiac health outcomes and access to care A supportive, fast-moving team environment typical of a growing med-tech company Flexibility to work from home Free on-site parking
The Role We're looking for a Quality Officer to join our growing team and help build the quality foundations that will support Lubdub's products through development, verification and eventual regulatory clearance. This is a hands-on, high-ownership role for an early-career professional who wants to build a career in medical device quality and regulatory affairs, working closely with our product, engineering and clinical teams across all three product lines.
The Quality Officer will support the implementation, maintenance and continual improvement of Lubdub’s Quality Management System. Working closely with the Head of Product and the broader product development team, the Quality Officer will assist with document control, quality records, design control, risk management, training, supplier quality and audit readiness. The role will also provide administrative and technical support for regulatory submissions and compliance activities.
Key Responsibilities
Quality Management System Help implement, maintain and improve the quality management system (QMS), including document control, quality records, tracking quality actions and reporting on quality metrics.
Product Development and Design Control Support design history files, design control records (inputs, outputs, reviews, verification and validation), risk management documentation, and change control across product, software and manufacturing.
Regulatory Support Help prepare and maintain regulatory/technical documentation, compile submission packages, and track compliance registers and relevant standards.
Audits and Compliance Support the preparation for internal/external audits and inspections, including gathering evidence, tracking findings, and keeping documentation audit ready.
Training and Quality Culture Coordinate quality training records, support onboarding, and help build a practical, positive quality culture across the team.
Supplier and Operational Quality Assist with supplier evaluation and records, and support operational quality tasks (inspections, calibration, product release) as the business grows.
Qualifications and Experience
Essential A degree in biomedical engineering, engineering, quality management, life sciences or a related discipline, or an equivalent combination of education and relevant experience Strong attention to detail and a commitment to maintaining accurate records Excellent written communication and document preparation skills Strong organisational and time management capabilities Ability to manage multiple tasks and follow activities through to completion Confidence working collaboratively across multidisciplinary teams Proficiency in Microsoft Office applications and the ability to learn new quality and document management systems
Desirable Previous experience in a quality, regulatory, engineering, laboratory, manufacturing or other regulated environment Knowledge of or exposure to ISO 13485 quality management systems Familiarity with medical device design controls, risk management or technical documentation Exposure to ISO 14971, Good Manufacturing Practice or other relevant quality standards Experience with document control, internal audits, CAPA, non-conformance management or supplier quality Understanding of Australian or international medical device regulatory requirements Experience within a start-up, scale-up or product development environment
Skills and Attributes The successful candidate will demonstrate: A structured, methodical and detail-oriented approach to work A willingness to learn and develop within the medical device quality field Sound judgement and the ability to recognise when an issue should be escalated Strong interpersonal skills and the ability to communicate quality requirements clearly Initiative and a practical approach to problem-solving Integrity, accountability and respect for confidentiality The ability to work effectively in a fast-paced and evolving environment An interest in contributing to technology that improves access to healthcare