At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeQuality 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. You will be a part of a team that supports day-to-day maintenance of the quality management system (QMS) and quality programs to ensure compliance with policies, regulations and standards. In addition, you will drive or support improvement activities to enhance our QMS strategy. This is a unique opportunity to apply your effort and skills to improving how people live their lives every day.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned:
Provides 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.
Provides 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.
Works 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.
Supports internal and external audit and inspection preparation, participates in audits, and ensures timely resolution and documentation of audit and inspection findings.
Prepares, reviews, and maintains quality documentation, including management review inputs, risk assessments, metrics, and key performance indicators (KPIs).
Leads or supports 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.
Ensures the quality management system (QMS) documentation and processes are maintained, updated, and improved to reflect current regulatory and business requirements.
Participates in change control, product release, and post-market surveillance activities to ensure compliance and effective risk management.
Collaborates globally to align on quality system processes, facilitate best practice sharing, and support harmonization of quality standards across regions.
Supports training and awareness initiatives to ensure quality culture and compliance throughout the organization.
Required Knowledge and Experience:
Bachelors degree required with minimum of 2 years of relevant experience
Medical device industry with relevant regulatory and standards knowledge
Working knowledge of ISO 13485, ISO 14971, and relevant TGA and international medical device regulations.
Audit Backroom and/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 are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
