Quality Systems Specialist

A Day in the Life Quality is everyone's responsibility Medtronic is a world leader in providing health‑care products that restore health and extend life. The Medtronic Diabetes Quality team contributes directly to this mission. We are looking for a Quality Systems Specialist to join the Australian Quality team to ensure a mature and compliant quality management system (QMS). In this role you will support day‑to‑day maintenance of the QMS and quality programs, ensuring compliance with policies, regulations, and standards. You will also drive or support improvement activities to strengthen our QMS strategy, helping us unlock our potential in a dynamic, innovative environment. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division, providing a bold opportunity to operate with greater speed and agility. We anticipate increased investments to drive meaningful innovation and enhance our impact on patient care. Responsibilities Provide oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures that ensure compliance with company policies and that the performance and quality of products and services conform to established internal and external standards, including ISO 13485 and applicable TGA regulatory requirements. Provide expertise and guidance to co‑workers in interpreting quality and regulatory requirements, including Australian Therapeutic Goods (Medical Devices) Regulations 2002, MDR (where applicable), and internal quality system procedures. Work directly with cross‑functional teams (e.g., Manufacturing, Supply Chain, Regulatory Affairs, and Service) to provide ongoing process analysis and quality oversight to ensure compliance, identify risks, and drive continuous improvement. Support internal and external audit and inspection preparation, participate in audits, and ensure timely resolution and documentation of audit and inspection findings. Prepare, review, and maintain quality documentation, including management review inputs, risk assessments, metrics, and key performance indicators (KPIs). Lead or support compliance‑related activities such as audit readiness, nonconformance management, root cause analysis, Corrective and Preventive Actions (CAPA), and continuous improvement initiatives. May act as lead or contributor for other quality functions including document control, software validation, supplier quality, and design control activities. Ensure the QMS documentation and processes are maintained, updated, and improved to reflect current regulatory and business requirements. Participate in change control, product release, and post‑market surveillance activities to ensure compliance and effective risk management. Collaborate globally to align on quality system processes, facilitate best‑practice sharing, and support harmonization of quality standards across regions. Support training and awareness initiatives to ensure quality culture and compliance throughout the organization. Required Knowledge and Experience Bachelor's degree with a minimum of 2 years of relevant experience. Medical device industry experience with relevant regulatory and standards knowledge. Working knowledge of ISO 13485, ISO 14971, and relevant TGA and international medical device regulations. Experience in audit (back‑room or front‑room) roles. Experience in CAPA, internal audits, and post‑market quality processes. Problem‑solving or process improvement methodology (e.g., Six Sigma, Lean, 5 Why, Kaizen). Physical Job Requirements The above statements describe the general nature and level of work performed by employees assigned to this position. They are not an exhaustive list of all responsibilities and skills required for this role. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. We recognize our employees' contributions and support them at every career and life stage. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly tackle the most challenging health problems facing humanity by providing solutions. Our mission – to alleviate pain, restore health, and extend life – unites a global team of over 95,000 passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people. From R&D labs to factory floors to conference rooms, we experiment, create, build, improve, and solve. We have the talent, diverse perspectives, and courage to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. Seniority level Associate Employment type Full‑time Job function Quality Assurance Industries Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing #J-18808-Ljbffr