Ra/Qa Specialist

Benefits Competitive salary package with career development opportunitiesFlexible work arrangements promoting work-life balanceCollaborative environment & broad roleAbout the company
Our client is a global leader in the medical technology space, specialising in the design and manufacture of cutting-edge medical devices. With a strong presence in both national and international markets, they are renowned for their innovation and commitment to improving patient outcomes.
About the opportunity
This is a crucial role where you will manage and maintain the QMS ensuring compliance with local and international regulatory requirements. You will report to the Senior Manager and work closely with cross-functional teams across R&D, manufacturing, and operations. Your contribution will directly impact the company's ability to bring new products to market, ensuring patient safety and product quality.
Duties Ensure compliance with ISO 13485 and other relevant regulationsOversee product registrations and regulatory submissionsConduct internal audits and manage CAPAsSupport post-market surveillance and risk management activitiesSkills and Experience Tertiary qualification in science or engineeringStrong understanding of ISO 13485 and TGA/MDRExperience with product registrations and submissionsExcellent communication and problem-solving skillsCulture
Join a forward-thinking, innovative company that values teamwork, continuous improvement, and high standards of quality. Their collaborative culture fosters professional growth and supports work-life balance.
How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on ******.

#J-18808-Ljbffr