Oversee internal manufacturing assembly process, maintenance of QMS Our client is an innovative MedTech company specialising in single-use sterile technology products for surgeons is gearing up for global expansion, building on its early sales success in Australia and Japan. They are looking for a Product Quality Engineer who will be responsible for ensuring that contract manufacturers produce high-quality product compliant with ISO 13485:2016, MDSAP, and applicable regulatory standards and for setting up and overseeing new internal manufacturing processes as the company grows. Technical qualifications and experience: Bachelor Degree or equivalent, Proven experience in the application of ISO 13485 and medical device manufacturing, Proven experience in Quality Engineering within the medical device industry, with a strong emphasis on internalising manufacturing processes, setting up, and qualifying manufacturing sites, Experience working in a manufacturing/clean room environment and managing asset management processes. Skills: Strong analytical and problem-solving skills, Effective written and oral communication Capable of working in a team High level of attention to detail About the role: Part-time (3-4 days a week) On-site Responsibilities: Develop and enforce quality control procedures throughout the production process to ensure consistent product standards, Participate in risk management efforts, identifying and addressing potential quality risks, Conduct validations for Quality Management System Software and support verification and validation activities to enhance the QMS, Assist in the implementation, monitoring, and upkeep of Quality Management System (QMS), ensuring alignment with ISO 13485:2016, MDSAP, and relevant regulatory standards, Supervise internal manufacturing assembly process, including training temporary staff, to ensure efficient production and maintain product quality, Manage and enhance asset management processes to optimise the use and maintenance of equipment and resources, Manage non-compliance issues (e.g., non-conformance reports, CAPA), ensuring timely corrective actions, Participate in post-market surveillance activities and undertake additional tasks as directed by the QA Manager, Serve as the Document Controller, ensuring accurate and compliant record-keeping for audit readiness, Address customer feedback and complaints, ensuring proper documentation and resolution. Support Management Reviews and Quality Assurance meetings to ensure the continued effectiveness of the QMS. If this opportunity resonates with you, we invite you to apply.