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. Responsibilities /Tasks: QA tasks – Must have hands-on experience in these tasks. Support the implementation, monitoring, and maintenance of the Quality Management System (QMS), ensuring compliance with ISO 13485:2016, MDSAP, and applicable regulatory requirements. Handle customer feedback, complaints and related communication, ensuring thorough documentation and resolution. Manage non-compliance issues (non-conformance reports, CAPA), ensuring timely resolution. Conduct Quality Management System Software validations and support verification and validation activities to strengthen the QMS. Act as a Document Controller, ensuring accurate record-keeping for compliance and audit readiness. Improve asset management processes to ensure efficient use and maintenance of equipment and resources. Production-related tasks: Execute in-house product assembly/manufacturing processes, incoming goods inspection, cleaning processes and aseptic handling, prepare batch documentation and product release. Develop and enforce quality control measures and procedures throughout the production process to maintain consistent product quality. Write work instructions, technical reports, technical procedures and administrative procedures. Additional / Nice to have: The ability to participate in risk management activities, identifying and mitigating potential quality risks. Able to perform gap assessments as required and manage the resolution process. Able to support Management Reviews and QA meetings to promote the QMS's effectiveness. Ability to engage in post-market surveillance activities and undertake additional responsibilities as directed by the QA Manager. 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. If this opportunity resonates with you, we invite you to apply.