Quality Lead

Key Responsibilities Your key responsibilities in leading and supporting the Quality Management processes and team are : Championing quality within the organization, towards fulfilling our corporate mission. Monitoring, maintaining and improving our purpose‑built Quality Management System in accordance with ISO and ISO standards. Ensuring overall compliance to standard operating procedures in line with the QMS. Developing audit programs and plans, performing internal audits and co‑ordinating external audits. Identifying, planning and documenting opportunities for improvement in company processes and systems and working with subject‑matter experts to drive implementation. Managing and processing CAPA related activities. Identifying and advising on relevant standards and regulation for product developments, maintaining up‑to‑date libraries of applicable standards and regulation across global markets. Facilitating company and product development risk management in accordance with best practices, including ISO IEC and ISO Facilitating appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development. Managing quality for the development of medical devices according to regulation such as CE MDR, FDA and TGA and standards including ISO IEC and IEC Managing the calibration of test and measurement equipment. Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection. Developing and conducting induction and training on QMS processes and policies, and promoting QMS regulatory requirements to all staff. Required Skills and Experience A relevant qualification from a reputable education organization. At least 5 years' experience in quality management or a similar role. In-depth knowledge of ISO and ISO , as well as regulatory requirements pertaining to product development. Understanding of a variety of production / manufacturing processes. Experience in communicating with and evaluating local and offshore suppliers. Excellent verbal and written English communication skills. Ability to work independently and as part of a team. Preferred Skills and Experience Quality management experience in product design and development. About Us If you are passionate about creating innovative, human‑centric products and want to do it as part of one of Australia's leading product design teams, this unique opportunity is for you Work on a diverse range of products, showcase your excellence in design and bring cutting‑edge products to life. We've created one of the largest multidisciplinary product development consulting teams in Australia, and we're continuing to grow. We provide comprehensive design services to leading Australian and international companies for a wide range of industries. These include consumer, commercial, sporting and leisure, industrial, automotive, biomedical, mining applications and more. Our development team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers and more. We provide a full turnkey service for our customers and a unique opportunity for creative, passionate, professional designers and engineers to continue to develop their skills with us. Location Our Sydney office is located in the North Ryde technology area with convenient access by road and public transport. We provide workplace flexibility by allowing staff to work from home for part of the week. Call to Action Ready to join the team? Fill out the job application form and preferred applicants will be contacted. #J-18808-Ljbffr